<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/NCT03775486</url>
  </required_header>
  <id_info>
    <org_study_id>D9102C00001</org_study_id>
    <secondary_id>2018-003460-30</secondary_id>
    <nct_id>NCT03775486</nct_id>
  </id_info>
  <brief_title>Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)</brief_title>
  <acronym>ORION</acronym>
  <official_title>A Phase II Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab Plus Olaparib Combination Therapy Compared With Durvalumab Monotherapy as Maintenance Therapy in Patients Whose Disease Has Not Progressed Following Standard of Care Platinum-Based Chemotherapy With Durvalumab in First Line Stage IV Non Small Cell Lung Cancer (ORION)</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, double-blind, multi-center, global Phase II study to determine the&#xD;
      efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab&#xD;
      monotherapy as maintenance therapy in patients whose disease has not progressed following&#xD;
      Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in&#xD;
      patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating&#xD;
      epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK)&#xD;
      fusions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adult patients with a histologically or cytologically documented advanced NSCLC not amenable&#xD;
      to curative surgery or radiation with tumors that lack activation EGFR mutations and ALK&#xD;
      fusions are eligible for enrollment. During the initial therapy phase, patients will receive&#xD;
      treatment with Durvalumab along with the Investigator's choice of platinum-based doublet&#xD;
      therapy for squamous NSCLC (nab-paclitaxel plus carboplatin or gemcitabine plus&#xD;
      carboplatin/cisplatin) and non-squamous NSCLC (nab-paclitaxel plus carboplatin or pemetrexed&#xD;
      plus carboplatin/cisplatin) for 4 cycles. Patients who have completed 4 cycles and not&#xD;
      progressed throughout the initial therapy phase will be randomized in a 1:1 ratio into the&#xD;
      maintenance phase of the study to receive either Durvalumab plus placebo or Durvalumab plus&#xD;
      Olaparib maintenance therapy. Patients will receive maintenance treatment until specific&#xD;
      discontinuation criteria are met, including clinical disease progression (as assessed by the&#xD;
      Investigator) or RECIST 1.1-defined radiological Progressive Disease (PD), unacceptable&#xD;
      toxicity, and withdrawal of consent. Tumor evaluation scans will be performed until objective&#xD;
      disease progression as efficacy assessments. All patients will be followed for survival until&#xD;
      the end of the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 21, 2018</start_date>
  <completion_date type="Anticipated">September 29, 2024</completion_date>
  <primary_completion_date type="Actual">January 11, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival</measure>
    <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
    <description>Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1.&#xD;
PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From randomization until the date of death due to any cause, up to 18 months.</time_frame>
    <description>Overall survival (OS) across the maintenance phase.&#xD;
OS is defined as time from date of randomization until the date of death by any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
    <description>Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>From date of first documented response until objective radiological disease progression or death, up to 18 months.</time_frame>
    <description>Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression.&#xD;
Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population</measure>
    <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
    <description>Progression-free survival in homologous recombination repair related gene mutation (HRRm) population defined as time from date of randomization until the date of objective radiological disease progression in HRRm population using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Durvalumab</measure>
    <time_frame>Assessed from start of initial therapy up to 2 years.</time_frame>
    <description>Concentration (pharmacokinetics) of durvalumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13</measure>
    <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
    <description>Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented.&#xD;
The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13</measure>
    <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
    <description>Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13.&#xD;
Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration.&#xD;
NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30</measure>
    <time_frame>Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months.</time_frame>
    <description>Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented.&#xD;
The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function.&#xD;
A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30</measure>
    <time_frame>From randomization until date of first symptom deterioration that is confirmed, up to 18 months.</time_frame>
    <description>Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30.&#xD;
NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Anti-drug Antibodies (ADAs) for Durvalumab</measure>
    <time_frame>Assessed from start of initial therapy up to 2 years.</time_frame>
    <description>Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Related Adverse Events</measure>
    <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
    <description>Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">401</enrollment>
  <condition>Non-small Cell Lung Cancer NSCLC</condition>
  <arm_group>
    <arm_group_label>Durvalumab/Olaparib Combination Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Durvalumab/Olaparib Combination Therapy:&#xD;
Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/Olaparib (maintenance phase)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Durvalumab Monotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Durvalumab Monotherapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/placebo (maintenance phase)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.</description>
    <arm_group_label>Durvalumab Monotherapy</arm_group_label>
    <arm_group_label>Durvalumab/Olaparib Combination Therapy</arm_group_label>
    <other_name>MEDI4736 (Durvalumab)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for Olaparib</intervention_name>
    <description>Matching tablet</description>
    <arm_group_label>Durvalumab Monotherapy</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required</description>
    <arm_group_label>Durvalumab/Olaparib Combination Therapy</arm_group_label>
    <other_name>AZD2281 (Olaparib)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel+carboplatin</intervention_name>
    <description>Standard of Care chemotherapy (squamous and non-squamous patients)</description>
    <arm_group_label>Durvalumab Monotherapy</arm_group_label>
    <arm_group_label>Durvalumab/Olaparib Combination Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine+carboplatin</intervention_name>
    <description>Standard of Care chemotherapy (squamous patients only)</description>
    <arm_group_label>Durvalumab Monotherapy</arm_group_label>
    <arm_group_label>Durvalumab/Olaparib Combination Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed+carboplatin</intervention_name>
    <description>Standard of Care chemotherapy (non-squamous patients only)</description>
    <arm_group_label>Durvalumab Monotherapy</arm_group_label>
    <arm_group_label>Durvalumab/Olaparib Combination Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine+cisplatin</intervention_name>
    <description>Standard of Care chemotherapy (squamous patients only)</description>
    <arm_group_label>Durvalumab Monotherapy</arm_group_label>
    <arm_group_label>Durvalumab/Olaparib Combination Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed+cisplatin</intervention_name>
    <description>Standard of Care chemotherapy (non-squamous patients only)</description>
    <arm_group_label>Durvalumab Monotherapy</arm_group_label>
    <arm_group_label>Durvalumab/Olaparib Combination Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Histologically or cytologically documented Stage IV NSCLC not amenable to curative&#xD;
        surgery or radiation.&#xD;
&#xD;
        Patients must have tumors that lack activating EGFR mutations and ALK fusions.&#xD;
&#xD;
          -  (WHO)/(ECOG) performance status of 0 or 1&#xD;
&#xD;
          -  No prior chemotherapy or any other systemic therapy for Stage IV NSCLC&#xD;
&#xD;
          -  Adequate organ and marrow function without blood transfusions in the past 28 days,&#xD;
&#xD;
          -  At least 1 tumor lesion, not previously irradiated, that can be accurately measured as&#xD;
             per RECIST 1.1.&#xD;
&#xD;
        Key Inclusion criteria for randomization to maintenance treatment:&#xD;
&#xD;
          -  Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per&#xD;
             Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy.&#xD;
&#xD;
          -  Creatinine Clearance (CrCl) ≥51 mL/min calculated by the investigator or designee&#xD;
             using the Cockcroft-Gault equation or measured by 24-hour urine collection.&#xD;
&#xD;
          -  Ability to swallow whole oral medications.&#xD;
&#xD;
          -  All patients must provide a formalin-fixed, paraffin embedded tumor sample for&#xD;
             tissue-based immunohistochemistry staining and DNA sequencing to determine PD-L1&#xD;
             expression, HRRm status, and other correlatives: either newly acquired or archival&#xD;
             tumor samples (&lt;3 years old) are acceptable. If available, a newly acquired tumor&#xD;
             biopsy, collected as part of routine clinical practice, is preferred. If not&#xD;
             available, an archival sample taken &lt;3 years prior to screening is acceptable. If both&#xD;
             an archival sample and a fresh tumor biopsy sample are available, both samples should&#xD;
             be submitted for analysis and must be submitted as different samples using different&#xD;
             accession numbers. Slides from different blocks cannot be mixed and submitted with the&#xD;
             same kit.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology.&#xD;
&#xD;
          -  Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for&#xD;
             non-metastatic disease), polyadenosine 5'diphosphoribose [poly (ADP ribose)]&#xD;
             polymerase (PARP) therapy, or immunomediated therapy&#xD;
&#xD;
          -  Active or prior documented autoimmune or inflammatory disorders.&#xD;
&#xD;
          -  Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.&#xD;
&#xD;
          -  Current or prior use of immunosuppressive medication within 14 days before the first&#xD;
             dose of Investigational Product (IP)&#xD;
&#xD;
          -  untreated (CNS) metastases and/or carcinomatous meningitis&#xD;
&#xD;
          -  Active infection.&#xD;
&#xD;
        Exclusion criteria to be randomized to maintenance treatment:&#xD;
&#xD;
        • Inability to complete 4 cycles of platinum-based chemotherapy for any reason or&#xD;
        discontinuation of Durvalumab during initial therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Myung-Ju Ahn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sungkyunkwan University School of Medicine, 135-710, Seoul, Korea</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bonita Springs</city>
        <state>Florida</state>
        <zip>34135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308-5304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</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>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</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>Deszk</city>
        <zip>6772</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Farkasgyepü</city>
        <zip>8582</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Törökbálint</city>
        <zip>2045</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ahmedabad</city>
        <zip>380009</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ahmedabad</city>
        <zip>380053</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jamnagar</city>
        <zip>361008</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kochi</city>
        <zip>682026</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mysuru</city>
        <zip>570021</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashik</city>
        <zip>422004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nashik</city>
        <zip>422005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pune</city>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Thiruvananthapuram</city>
        <zip>695011</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chuo-ku</city>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kanazawa-shi</city>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kurume-shi,</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Matsuyama-shi</city>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
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        <zip>354000</zip>
        <country>Russian Federation</country>
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        <zip>197022</zip>
        <country>Russian Federation</country>
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        <zip>49102</zip>
        <country>Ukraine</country>
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        <city>Kharkiv Region</city>
        <zip>61024</zip>
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        <zip>65055</zip>
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        <zip>DD1 9SY</zip>
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      <address>
        <city>Hull</city>
        <zip>HU6 7RX</zip>
        <country>United Kingdom</country>
      </address>
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  <location_countries>
    <country>Belgium</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
    <country>Romania</country>
  </removed_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D9102C00001&amp;amp;attachmentIdentifier=7fc7ec56-03b5-4150-b2a0-175391e8a8e5&amp;amp;fileName=d9102c00001-protocol-redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D9102C00001&amp;amp;attachmentIdentifier=22ea3b89-1cbe-40a5-8901-06e2cc9b0847&amp;amp;fileName=d9102c00001-sap-redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D9102C00001&amp;amp;attachmentIdentifier=4ac3bc35-f8da-4837-9436-b2bc09aca172&amp;amp;fileName=d9102c00001-study-synopsis-redacted.pdf&amp;amp;versionIdentifier=</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <results_first_submitted>July 4, 2022</results_first_submitted>
  <results_first_submitted_qc>November 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 12, 2022</results_first_posted>
  <disposition_first_submitted>December 8, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>November 15, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 12, 2022</disposition_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NSCLC</keyword>
  <keyword>Durvalumab</keyword>
  <keyword>Olaparib</keyword>
  <keyword>Maintenance</keyword>
  <keyword>Homologous Recombination Repair (HRR)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Durvalumab</mesh_term>
    <mesh_term>Olaparib</mesh_term>
    <mesh_term>Antibodies, Monoclonal</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:&#xD;
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>July 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03775486/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>November 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT03775486/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Initial therapy phase included participants who received durvalumab in combination with platinum based doublet chemotherapy.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Durvalumab/Olaparib Combination Therapy</title>
          <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
        </group>
        <group group_id="P2">
          <title>Durvalumab/Placebo Therapy</title>
          <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Initial Therapy Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">All 401 participants received the same initial therapy prior to randomization. As such, the subjects listed under the placebo arm for this period are representative of all subjects in the initial therapy phase.</participants>
                <participants group_id="P2" count="401">All 401 participants received the same initial therapy prior to randomization. As such, the subjects listed under the placebo arm for this period are representative of all subjects in the initial therapy phase.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="269"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="132"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Other reason provided</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Condition under investigation worsened</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="67"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Maintenance Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="134">All participants received the same initial therapy prior to randomization.</participants>
                <participants group_id="P2" count="135">All participants received the same initial therapy prior to randomization.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Who Received Durvalumab</title>
              <participants_list>
                <participants group_id="P1" count="134"/>
                <participants group_id="P2" count="134"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Who Received Olaparib/Placebo</title>
              <participants_list>
                <participants group_id="P1" count="128"/>
                <participants group_id="P2" count="128"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Participants Who Terminated the Study</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="57"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="44"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The full analysis set for the maintenance phase is presented</population>
      <group_list>
        <group group_id="B1">
          <title>Durvalumab/Olaparib Combination Therapy</title>
          <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
        </group>
        <group group_id="B2">
          <title>Durvalumab/Placebo Therapy</title>
          <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</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="134"/>
            <count group_id="B2" value="135"/>
            <count group_id="B3" value="269"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age at screening</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Mean age (years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.9" spread="9.59"/>
                    <measurement group_id="B2" value="63.0" spread="9.50"/>
                    <measurement group_id="B3" value="64.5" spread="9.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <description>Age at screening</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Less than 50 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Equal to or greater than 50 years to less than 65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Equal to or greater than 65 years to less than 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Equal to or greater than 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="36"/>
                  </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="36"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="132"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="264"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="185"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <description>Smoking status at screening</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Current</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Former</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Histology Type</title>
          <description>Histology type at screening</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Squamous Cell Carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nonsquamous Cell Carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>World Health Organization/Eastern Cooperative Oncology Group</title>
          <description>World Health Organization/Eastern Cooperative Oncology Group measurements at baseline were collected prior to start of maintenance phase.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Normal Activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Restricted Activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>In Bed Less Than or Equal to 50 percent of the Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival</title>
        <description>Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1.&#xD;
PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).</description>
        <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
        <population>Full analysis set (maintenance phase)</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival</title>
          <description>Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1.&#xD;
PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).</description>
          <population>Full analysis set (maintenance phase)</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="134"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>RECIST progression: Target Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST progression: Non Target Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST progression: New Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death in the absence of progression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Censored RECIST progression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Censored death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Progression-free at time of analysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Progression-free prior to lost to follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Progression-free prior to withdrawal of consent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Progression-free prior to discontinuation due to other reason</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: No post-baseline evaluable tumor assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.074</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Median progression-free survival (months)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median</param_type>
            <param_value>7.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.3</ci_lower_limit>
            <ci_upper_limit>7.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Median progression-free survival (months)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median</param_type>
            <param_value>5.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.7</ci_lower_limit>
            <ci_upper_limit>5.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival (OS) across the maintenance phase.&#xD;
OS is defined as time from date of randomization until the date of death by any cause</description>
        <time_frame>From randomization until the date of death due to any cause, up to 18 months.</time_frame>
        <population>Full analysis set (maintenance phase)</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival (OS) across the maintenance phase.&#xD;
OS is defined as time from date of randomization until the date of death by any cause</description>
          <population>Full analysis set (maintenance phase)</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="134"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored participants (still in survival at follow up or terminated study prior to death)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="90"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.604</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>1.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Median overall survival (months)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median</param_type>
            <param_value>17.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.1</ci_lower_limit>
            <ci_upper_limit_na_comment>NA = insufficient number of participants with events</ci_upper_limit_na_comment>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Median overall survival (months)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median overall survival (months)</param_type>
            <param_value>11.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>11.8</ci_lower_limit>
            <ci_upper_limit_na_comment>NA = insufficient number of participants with events</ci_upper_limit_na_comment>
            <estimate_desc>The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate</title>
        <description>Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization</description>
        <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
        <population>Full analysis set for maintenance phase, participants with measurable disease at baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate</title>
          <description>Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization</description>
          <population>Full analysis set for maintenance phase, participants with measurable disease at baseline</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="129"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response</title>
        <description>Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression.&#xD;
Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method.</description>
        <time_frame>From date of first documented response until objective radiological disease progression or death, up to 18 months.</time_frame>
        <population>Participants with a response and with measurable disease at baseline from the full analysis set (maintenance phase)</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response</title>
          <description>Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression.&#xD;
Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method.</description>
          <population>Participants with a response and with measurable disease at baseline from the full analysis set (maintenance phase)</population>
          <units>percent</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of participants remaining in response at 3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.5"/>
                    <measurement group_id="O2" value="85.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants remaining in response at 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.1"/>
                    <measurement group_id="O2" value="65.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants remaining in response at 9 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2"/>
                    <measurement group_id="O2" value="65.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of participants remaining in response at 12 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.2"/>
                    <measurement group_id="O2" value="65.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Median duration of response (months)</non_inferiority_desc>
            <param_type>Median duration of response</param_type>
            <param_value>6.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.5</ci_lower_limit>
            <ci_upper_limit_na_comment>NA = insufficient number of participants with events</ci_upper_limit_na_comment>
            <estimate_desc>The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Median duration of response (months)</non_inferiority_desc>
            <param_type>Median duration of response</param_type>
            <param_value>3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.8</ci_lower_limit>
            <ci_upper_limit_na_comment>NA = insufficient number of participants with events</ci_upper_limit_na_comment>
            <estimate_desc>The CI lower limit is included as the estimated value as there was an insufficient number of participants with events to calculate a median value</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population</title>
        <description>Progression-free survival in homologous recombination repair related gene mutation (HRRm) population defined as time from date of randomization until the date of objective radiological disease progression in HRRm population using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).</description>
        <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
        <population>Full analysis set (maintenance phase); HRRm subgroup</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population</title>
          <description>Progression-free survival in homologous recombination repair related gene mutation (HRRm) population defined as time from date of randomization until the date of objective radiological disease progression in HRRm population using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).</description>
          <population>Full analysis set (maintenance phase); HRRm subgroup</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="5"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>RECIST progression: Target Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST progression: Non Target Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RECIST progression: New Lesions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death in the absence of progression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Censored RECIST progression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Censored death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Progression-free at time of analysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Progression-free prior to lost to follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Progression-free prior to withdrawal of consent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: Progression-free prior to discontinuation due to other reason</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Censored subjects: No post-baseline evaluable tumor assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.07</ci_lower_limit>
            <ci_upper_limit>2.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Median progression-free survival (months)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median (months)</param_type>
            <param_value>3.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.7</ci_lower_limit>
            <ci_upper_limit_na_comment>NA = insufficient number of participants with events</ci_upper_limit_na_comment>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Median progression-free survival (months)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Median (months)</param_type>
            <param_value>3.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.2</ci_lower_limit>
            <ci_upper_limit>16.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration of Durvalumab</title>
        <description>Concentration (pharmacokinetics) of durvalumab</description>
        <time_frame>Assessed from start of initial therapy up to 2 years.</time_frame>
        <population>Pharmacokinetic analysis set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Durvalumab</title>
          <description>Concentration (pharmacokinetics) of durvalumab</description>
          <population>Pharmacokinetic analysis set</population>
          <units>μg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 01 Day 01 (Initial Therapy Phase) Post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="417.152" spread="62.694"/>
                    <measurement group_id="O2" value="453.724" spread="43.258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 02 Day 01 (Initial Therapy Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="129"/>
                    <count group_id="O2" value="130"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.812" spread="84.586"/>
                    <measurement group_id="O2" value="76.959" spread="71.104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 04 Day 01 (Initial Therapy Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="127"/>
                    <count group_id="O2" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155.461" spread="58.251"/>
                    <measurement group_id="O2" value="154.947" spread="50.102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 03 (Initial Therapy Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Cycle 01 (Maintenance Phase) Post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="535.078" spread="40.119"/>
                    <measurement group_id="O2" value="524.306" spread="56.458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 02 (Maintenance Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="119"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.157" spread="53.813"/>
                    <measurement group_id="O2" value="160.315" spread="54.409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 05 (Maintenance Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166.644" spread="54.948"/>
                    <measurement group_id="O2" value="147.848" spread="56.204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 08 (Maintenance Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="46"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="198.932" spread="47.024"/>
                    <measurement group_id="O2" value="154.057" spread="54.911"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11 (Maintenance Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210.794" spread="42.117"/>
                    <measurement group_id="O2" value="186.092" spread="39.823"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 14 (Maintenance Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="276.612" spread="50.137"/>
                    <measurement group_id="O2" value="182.042" spread="39.341"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 17 (Maintenance Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="264.096" spread="55.519"/>
                    <measurement group_id="O2" value="217.137" spread="92.229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 20 (Maintenance Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="528.046"/>
                    <measurement group_id="O2" value="112.276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 03 (Maintenance Phase) Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.289" spread="450.125"/>
                    <measurement group_id="O2" value="12.769" spread="225.898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13</title>
        <description>Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented.&#xD;
The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity.</description>
        <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
        <population>Full analysis set (maintenance phase)</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13</title>
          <description>Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented.&#xD;
The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity.</description>
          <population>Full analysis set (maintenance phase)</population>
          <units>change from baseline score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC QLQ-LC13: Dyspnoea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.27" spread="1.373"/>
                    <measurement group_id="O2" value="-0.76" spread="1.500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13: Coughing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.14" spread="1.980"/>
                    <measurement group_id="O2" value="-3.09" spread="2.172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13: Pain in chest</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" spread="1.410"/>
                    <measurement group_id="O2" value="3.57" spread="1.575"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EORTC QLQ-LC13: Dyspnoea Estimated difference in adjusted mean change from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Estimated difference in adjusted mean</param_type>
            <param_value>-0.51</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.47</ci_lower_limit>
            <ci_upper_limit>3.46</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EORTC QLQ-LC13: Coughing Estimated difference in adjusted mean change from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Estimated difference in adjusted mean</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.81</ci_lower_limit>
            <ci_upper_limit>6.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EORTC QLQ-LC13: Pain in chest Estimated difference in adjusted mean change from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Estimated difference in adjusted mean</param_type>
            <param_value>-2.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.39</ci_lower_limit>
            <ci_upper_limit>1.88</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13</title>
        <description>Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13.&#xD;
Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration.&#xD;
NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</description>
        <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
        <population>Full analysis set (maintenance phase)</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13</title>
          <description>Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13.&#xD;
Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration.&#xD;
NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</description>
          <population>Full analysis set (maintenance phase)</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="134"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC QLQ-LC13: Dyspnoea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="5.6" upper_limit="12.2"/>
                    <measurement group_id="O2" value="9.7" lower_limit="6.9" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13: Coughing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="132"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" lower_limit="9.3" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="10.6" lower_limit="7.7" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13: Haemoptysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="11.7" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="12.6" lower_limit="10.9" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13: Pain In Chest</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8" lower_limit="10.8" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="11.5" lower_limit="9.5" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13: Pain In Arm Or Shoulder</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="10.2" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="9.7" lower_limit="7.4" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-LC13: Pain In Other Parts</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="8.8" upper_limit="12.2"/>
                    <measurement group_id="O2" value="10.6" lower_limit="8.6" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30</title>
        <description>Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented.&#xD;
The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function.&#xD;
A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.</description>
        <time_frame>Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months.</time_frame>
        <population>Full analysis set (maintenance phase)</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30</title>
          <description>Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented.&#xD;
The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function.&#xD;
A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.</description>
          <population>Full analysis set (maintenance phase)</population>
          <units>change from baseline score</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="134"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC QLQ-C30: Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.15" spread="1.327"/>
                    <measurement group_id="O2" value="-1.49" spread="1.456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30: Appetite loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="112"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.13" spread="1.613"/>
                    <measurement group_id="O2" value="-3.35" spread="1.779"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EORTC QLQ-C30: Fatigue Estimated difference in adjusted mean change from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Estimated difference in adjusted mean</param_type>
            <param_value>1.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.20</ci_lower_limit>
            <ci_upper_limit>5.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EORTC QLQ-C30: Appetite loss Estimated difference in adjusted mean change from baseline.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Estimated difference in adjusted mean</param_type>
            <param_value>3.22</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.46</ci_lower_limit>
            <ci_upper_limit>7.90</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30</title>
        <description>Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30.&#xD;
NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</description>
        <time_frame>From randomization until date of first symptom deterioration that is confirmed, up to 18 months.</time_frame>
        <population>Full analysis set (maintenance phase)</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30</title>
          <description>Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30.&#xD;
NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</description>
          <population>Full analysis set (maintenance phase)</population>
          <units>time to deterioration (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="134"/>
                <count group_id="O2" value="135"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EORTC QLQ-C30: Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="5.6" upper_limit="10.8"/>
                    <measurement group_id="O2" value="10" lower_limit="8.0" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30: Nausea And Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="10.2" upper_limit="15.0"/>
                    <measurement group_id="O2" value="12.6" lower_limit="9.7" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30: Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" lower_limit="7.4" upper_limit="12.2"/>
                    <measurement group_id="O2" value="9.7" lower_limit="6.6" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30: Dyspnoea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="10.0" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="11.0" lower_limit="8.8" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30: Insomnia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8" lower_limit="10.0" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="10.6" lower_limit="8.6" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30: Appetite Loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="131"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" lower_limit="10.1" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="11.5" lower_limit="10.0" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30: Constipation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="10.0" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="12.0" lower_limit="10.0" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EORTC QLQ-C30: Diarrhoea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.8" lower_limit="10.2" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="11.5" lower_limit="9.7" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="9.3" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="12.0" lower_limit="9.0" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Role Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="5.6" upper_limit="12.2"/>
                    <measurement group_id="O2" value="10.6" lower_limit="8.8" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="9.3" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="11.0" lower_limit="8.8" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cognitive Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" lower_limit="6.9" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                    <measurement group_id="O2" value="10.6" lower_limit="8.6" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="134"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.3" lower_limit="7.4" upper_limit="12.2"/>
                    <measurement group_id="O2" value="10.0" lower_limit="7.7" upper_limit="NA">NA is &quot;not applicable&quot;. The upper confidence limit was not calculable because of an insufficient number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Global Health Status/Quality of Life</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="134"/>
                    <count group_id="O2" value="133"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" lower_limit="6.5" upper_limit="12.2"/>
                    <measurement group_id="O2" value="9.7" lower_limit="7.4" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Anti-drug Antibodies (ADAs) for Durvalumab</title>
        <description>Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab</description>
        <time_frame>Assessed from start of initial therapy up to 2 years.</time_frame>
        <population>Anti-drug antibody (ADA) evaluable set</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Anti-drug Antibodies (ADAs) for Durvalumab</title>
          <description>Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab</description>
          <population>Anti-drug antibody (ADA) evaluable 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="132"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA prevalence (any ADA positive, baseline or post-baseline)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA incidence (treatment-induced or treatment-boosted)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline and positive at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA positive post-baseline and not detected at baseline (treatment-induced)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA not detected at post-baseline and positive at baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-boosted ADA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transient positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutralizing anti-drug antibody positive at any visit</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Related Adverse Events</title>
        <description>Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)</description>
        <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months</time_frame>
        <population>Safety analysis set.&#xD;
One participant randomized to the durvalumab/placebo group did not receive any durvalumab or placebo and was excluded from the safety analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>Durvalumab/Olaparib Combination Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
          </group>
          <group group_id="O2">
            <title>Durvalumab/Placebo Therapy</title>
            <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Related Adverse Events</title>
          <description>Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)</description>
          <population>Safety analysis set.&#xD;
One participant randomized to the durvalumab/placebo group did not receive any durvalumab or placebo and was excluded from the safety 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="134"/>
                <count group_id="O2" value="134"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months.</time_frame>
      <desc>Adverse events and serious adverse events for the safety analysis set during the Maintenance Phase are presented. Deaths for the full analysis set during the Maintenance Phase are presented. The safety analysis set had 1 fewer participant than the full analysis set as 1 participant randomized did not receive durvalumab or placebo and was therefore not included.&#xD;
Frequency Threshold for reporting Other Adverse Events: 5 percent&#xD;
0 = &lt;5% of events reported</desc>
      <group_list>
        <group group_id="E1">
          <title>Initial Therapy Phase</title>
          <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle</description>
        </group>
        <group group_id="E2">
          <title>Durvalumab/Olaparib Combination Therapy</title>
          <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily</description>
        </group>
        <group group_id="E3">
          <title>Durvalumab/Placebo Therapy</title>
          <description>Initial Therapy Phase (up to 4 cycles):&#xD;
Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows:&#xD;
Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle&#xD;
Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle&#xD;
Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle&#xD;
Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle&#xD;
Followed by Maintenance Phase:&#xD;
Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="89" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="45" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="104" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Cardiovascular insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pericardial haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Secondary adrenocortical insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Catheter site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Meningitis pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Sialoadenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Abscess oral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Gastrointestinal bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Meningoencephalitis herpetic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pneumonia necrotising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Viral diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Radiation oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Influenza A virus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Influenza B virus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </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" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Renal infarct</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Superior vena cava syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Vena cava thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="368" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="116" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="104" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="188" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="118" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="35" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="134"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="401"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="134"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="134"/>
              </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>The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years of completion of the Study shall require the Sponsor's prior written consent.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Lead</name_or_title>
      <organization>AstraZeneca</organization>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03775486
org study id: D9102C00001
secondary id: 2018-003460-30
nct id: NCT03775486
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blind, multi-center, global Phase II study to determine the
      efficacy and safety of Durvalumab plus Olaparib combination therapy compared with Durvalumab
      monotherapy as maintenance therapy in patients whose disease has not progressed following
      Standard of Care (SoC) platinum-based chemotherapy with Durvalumab as first-line treatment in
      patients with Stage IV non small-cell lung cancer (NSCLC) with tumors that lack activating
      epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK)
      fusions.
Adult patients with a histologically or cytologically documented advanced NSCLC not amenable
      to curative surgery or radiation with tumors that lack activation EGFR mutations and ALK
      fusions are eligible for enrollment. During the initial therapy phase, patients will receive
      treatment with Durvalumab along with the Investigator's choice of platinum-based doublet
      therapy for squamous NSCLC (nab-paclitaxel plus carboplatin or gemcitabine plus
      carboplatin/cisplatin) and non-squamous NSCLC (nab-paclitaxel plus carboplatin or pemetrexed
      plus carboplatin/cisplatin) for 4 cycles. Patients who have completed 4 cycles and not
      progressed throughout the initial therapy phase will be randomized in a 1:1 ratio into the
      maintenance phase of the study to receive either Durvalumab plus placebo or Durvalumab plus
      Olaparib maintenance therapy. Patients will receive maintenance treatment until specific
      discontinuation criteria are met, including clinical disease progression (as assessed by the
      Investigator) or RECIST 1.1-defined radiological Progressive Disease (PD), unacceptable
      toxicity, and withdrawal of consent. Tumor evaluation scans will be performed until objective
      disease progression as efficacy assessments. All patients will be followed for survival until
      the end of the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Progression-free Survival
time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
description: Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1.
PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).
measure: Overall Survival
time frame: From randomization until the date of death due to any cause, up to 18 months.
description: Overall survival (OS) across the maintenance phase.
OS is defined as time from date of randomization until the date of death by any cause
measure: Objective Response Rate
time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
description: Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization
measure: Duration of Response
time frame: From date of first documented response until objective radiological disease progression or death, up to 18 months.
description: Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression.
Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method.
measure: Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population
time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
description: Progression-free survival in homologous recombination repair related gene mutation (HRRm) population defined as time from date of randomization until the date of objective radiological disease progression in HRRm population using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).
measure: Concentration of Durvalumab
time frame: Assessed from start of initial therapy up to 2 years.
description: Concentration (pharmacokinetics) of durvalumab
measure: Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
description: Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented.
The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity.
measure: Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13
time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
description: Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13.
Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration.
NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
measure: Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
time frame: Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months.
description: Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented.
The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function.
A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
measure: Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30
time frame: From randomization until date of first symptom deterioration that is confirmed, up to 18 months.
description: Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30.
NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
measure: Presence of Anti-drug Antibodies (ADAs) for Durvalumab
time frame: Assessed from start of initial therapy up to 2 years.
description: Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab
measure: Number of Participants With Treatment-Related Adverse Events
time frame: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months
description: Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)
arm group label: Durvalumab/Olaparib Combination Therapy
arm group type: Experimental
description: Durvalumab/Olaparib Combination Therapy:
Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/Olaparib (maintenance phase)
arm group label: Durvalumab Monotherapy
arm group type: Experimental
description: Durvalumab Monotherapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/placebo (maintenance phase)
intervention type: Drug
intervention name: Durvalumab
description: Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.
arm group label: Durvalumab Monotherapy
arm group label: Durvalumab/Olaparib Combination Therapy
other name: MEDI4736 (Durvalumab)
intervention type: Drug
intervention name: Placebo for Olaparib
description: Matching tablet
arm group label: Durvalumab Monotherapy
other name: Placebo
intervention type: Drug
intervention name: Olaparib
description: 150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required
arm group label: Durvalumab/Olaparib Combination Therapy
other name: AZD2281 (Olaparib)
intervention type: Drug
intervention name: Nab-paclitaxel+carboplatin
description: Standard of Care chemotherapy (squamous and non-squamous patients)
arm group label: Durvalumab Monotherapy
arm group label: Durvalumab/Olaparib Combination Therapy
intervention type: Drug
intervention name: Gemcitabine+carboplatin
description: Standard of Care chemotherapy (squamous patients only)
arm group label: Durvalumab Monotherapy
arm group label: Durvalumab/Olaparib Combination Therapy
intervention type: Drug
intervention name: Pemetrexed+carboplatin
description: Standard of Care chemotherapy (non-squamous patients only)
arm group label: Durvalumab Monotherapy
arm group label: Durvalumab/Olaparib Combination Therapy
intervention type: Drug
intervention name: Gemcitabine+cisplatin
description: Standard of Care chemotherapy (squamous patients only)
arm group label: Durvalumab Monotherapy
arm group label: Durvalumab/Olaparib Combination Therapy
intervention type: Drug
intervention name: Pemetrexed+cisplatin
description: Standard of Care chemotherapy (non-squamous patients only)
arm group label: Durvalumab Monotherapy
arm group label: Durvalumab/Olaparib Combination Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Myung-Ju Ahn, MD
role: Principal Investigator
affiliation: Sungkyunkwan University School of Medicine, 135-710, Seoul, Korea
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country: Belgium
country: Hungary
country: India
country: Japan
country: Korea, Republic of
country: Mexico
country: Netherlands
country: Poland
country: Russian Federation
country: Ukraine
country: United Kingdom
country: United States
country: France
country: Romania
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9102C00001&amp;attachmentIdentifier=7fc7ec56-03b5-4150-b2a0-175391e8a8e5&amp;fileName=d9102c00001-protocol-redacted.pdf&amp;versionIdentifier=
description: Related Info
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9102C00001&amp;attachmentIdentifier=22ea3b89-1cbe-40a5-8901-06e2cc9b0847&amp;fileName=d9102c00001-sap-redacted.pdf&amp;versionIdentifier=
description: Related Info
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9102C00001&amp;attachmentIdentifier=4ac3bc35-f8da-4837-9436-b2bc09aca172&amp;fileName=d9102c00001-study-synopsis-redacted.pdf&amp;versionIdentifier=
description: Related Info
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Cisplatin
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Pemetrexed
mesh term: Durvalumab
mesh term: Olaparib
mesh term: Antibodies, Monoclonal
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: 