<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/NCT02184195</url>
  </required_header>
  <id_info>
    <org_study_id>D081FC00001</org_study_id>
    <secondary_id>2014-001589-85</secondary_id>
    <nct_id>NCT02184195</nct_id>
  </id_info>
  <brief_title>Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy</brief_title>
  <acronym>POLO</acronym>
  <official_title>A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Myriad Genetic Laboratories, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance&#xD;
      Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose&#xD;
      Disease Has Not Progressed on First Line Platinum Based Chemotherapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately 145 patients will be randomised using an Interactive Voice Response System&#xD;
      /Interactive Web Response System (IVR/IWR system) in a 3:2 ratio (Olaparib:placebo) to the&#xD;
      treatments as specified below:&#xD;
&#xD;
        -  Olaparib tablets p.o. 300 mg twice daily&#xD;
&#xD;
        -  Matching placebo tablets p.o. twice daily Eligible patients will be those patients with&#xD;
           pancreas cancer previously treated for metastatic disease who have not progressed&#xD;
           following completion of at least 16 weeks (can be more) of first line platinum-based&#xD;
           chemotherapy. All patients must have a known deleterious or suspected deleterious&#xD;
           germline BRCA mutation to be randomised; this may have been determined prior to&#xD;
           enrolment into the study or may be assessed as part of the enrolment procedure for the&#xD;
           study (via centrally provided MyriadIntegrated BRAC.&#xD;
&#xD;
      Patients will be randomised within 6 weeks after their last dose of chemotherapy (last dose&#xD;
      is the day of the last infusion) and treatment started as soon as possible but no less than 4&#xD;
      and no more than 8 weeks of the last chemotherapy dose. At the time of starting protocol&#xD;
      treatment, all previous chemotherapy treatment should be discontinued.&#xD;
&#xD;
      Following randomisation, patients will attend clinic visits weekly for the first 4 weeks of&#xD;
      treatment (Days 8, 15, 22 and 29). Patients will then attend clinic visits every 4 weeks&#xD;
      whilst on study treatment. Patients should continue to receive study treatment until&#xD;
      objective radiological disease progression as per RECIST as assessed by the investigator and&#xD;
      as long as in the investigator's opinion they are benefiting from treatment and they do not&#xD;
      meet any other discontinuation criteria.&#xD;
&#xD;
      Once a patient has progressed the patient will be followed for second progression (PFS2)&#xD;
      every 8 weeks and then survival until the final analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 16, 2014</start_date>
  <completion_date type="Actual">January 27, 2023</completion_date>
  <primary_completion_date type="Actual">January 15, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Upto 4 years</time_frame>
    <description>To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomisation to Second Progression (PFS2)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomisation to Second Subsequent Therapy or Death (TSST)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomisation to First Subsequent Therapy or Death (TFST)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Randomisation to Study Treatment Discontinuation or Death (TDT)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1</measure>
    <time_frame>At 16 weeks</time_frame>
    <description>Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire</measure>
    <time_frame>From baseline up to 6 months</time_frame>
    <description>To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.&#xD;
A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.&#xD;
bd twice daily.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs)</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Germline BRCA1/2 Mutations and</condition>
  <condition>Metastatic Adenocarcinoma of the Pancreas</condition>
  <arm_group>
    <arm_group_label>Olaparib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Olaparib tablets po. 300 mg twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo tablets twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>Tablet -100mg</description>
    <arm_group_label>Olaparib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Olaparib</intervention_name>
    <description>Tablet-150mg</description>
    <arm_group_label>Olaparib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Match Olaparib 100mg placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Match Olaparib 150mg placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria&#xD;
&#xD;
          -  Histologically or cytologically confirmed pancreas adenocarcinoma receiving initial&#xD;
             chemotherapy for metastatic disease and without evidence of disease progression on&#xD;
             treatment&#xD;
&#xD;
          -  Patients with measurable disease and/or non-measurable or no evidence of disease&#xD;
             assessed at baseline by CT (or MRI where CT is contraindicated) will be entered in&#xD;
             this study.&#xD;
&#xD;
          -  Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or&#xD;
             suspected deleterious&#xD;
&#xD;
          -  Patients are on treatment with a first line platinum-based (cisplatin, carboplatin or&#xD;
             oxaliplatin) regimen for metastatic pancreas cancer, have received a minimum of 16&#xD;
             weeks of continuous platinum treatment and have no evidence of progression based on&#xD;
             investigator's opinion.&#xD;
&#xD;
          -  Patients who have received platinum as potentially curative treatment for a prior&#xD;
             cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for pancreas cancer&#xD;
             are eligible provided at least 12 months have elapsed between the last dose of&#xD;
             platinum-based treatment and initiation of the platinum-based chemotherapy for&#xD;
             metastatic pancreas cancer.&#xD;
&#xD;
        Major Exclusion Criteria:&#xD;
&#xD;
          -  gBRCA1 and/or gBRCA2 mutations that are considered to be non detrimental (eg,&#xD;
             &quot;Variants of uncertain clinical significance&quot; or &quot;Variant of unknown significance&quot; or&#xD;
             &quot;Variant, favour polymorphism&quot; or &quot;benign polymorphism&quot; etc.)&#xD;
&#xD;
          -  Progression of tumour between start of first line platinum based chemotherapy for&#xD;
             metastatic pancreas cancer and randomisation.&#xD;
&#xD;
          -  Cytotoxic chemotherapy or non-hormonal targeted therapy within 28 days of Cycle&#xD;
&#xD;
             1 Day 1 is not permitted.&#xD;
&#xD;
          -  Exposure to an investigational product within 30 days or 5 half lives (whichever is&#xD;
             longer) prior to randomisation&#xD;
&#xD;
          -  Any previous treatment with a PARP inhibitor, including Olaparib&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305-5720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Campbelltown</city>
        <zip>2560</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Randwick</city>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>St Leonards</city>
        <zip>2065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Antwerpen</city>
        <zip>2020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brussel</city>
        <zip>1070</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>London</city>
        <state>Ontario</state>
        <zip>N6A 4L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1G 2E8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Besançon</city>
        <zip>25000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brest Cedex</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Clichy Cedex</city>
        <zip>92118</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Roche sur Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lille</city>
        <zip>59020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lyon Cedex 03</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paris CEDEX 14</city>
        <zip>75674</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>STRASBOURG Cedex</city>
        <zip>67065</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Villejuif</city>
        <zip>94800</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>10967</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Berlin</city>
        <zip>D-13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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      <address>
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        <country>Spain</country>
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      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
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        <zip>EH4 2XR</zip>
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        <zip>G12 0YN</zip>
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        <zip>M20 4BX</zip>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Northwood</city>
        <zip>HA6 2RN</zip>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Surrey</city>
        <zip>SM1 2DL</zip>
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      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D081FC00001&amp;amp;attachmentIdentifier=9095e288-3d26-4c56-87dd-5dedc61f25c2&amp;amp;fileName=POLO_Revised_CSP_2-24Jul2019_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=D081FC00001&amp;amp;attachmentIdentifier=42f897a4-b682-4a0f-b2b0-cecf3f143423&amp;amp;fileName=D081FC00001_Redacted_SAP.pdf&amp;amp;versionIdentifier=</url>
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  <link>
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    <description>Related Info</description>
  </link>
  <reference>
    <citation>Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2.</citation>
    <PMID>31157963</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <results_first_submitted>January 14, 2020</results_first_submitted>
  <results_first_submitted_qc>January 14, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">January 27, 2020</results_first_posted>
  <last_update_submitted>August 18, 2023</last_update_submitted>
  <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BRCA, metastatic adenocarcinoma pancreas, maintenance olaparib monotherapy, first line platinum chemotherapy, pancreatic cancer, PARP inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Olaparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT02184195/Prot_002.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>January 31, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/95/NCT02184195/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study randomised patients at a total of 59 study centres in 12 countries: United States of America (13), Germany (8), France (7), Israel (7), Spain (7), United Kingdom (6), Italy (4), Belgium (2), Republic of Korea (2), Australia (1), Canada (1) and Netherlands (1).</recruitment_details>
      <pre_assignment_details>Screening Part 1 was only required if a patient's gBRCAm status was unknown and Screening Part 2 was for patients with known local germline BRCA (gBRCA) test. All other screening parameters were done as per the Study Schedule.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Olaparib 300 mg Twice Daily (bd)</title>
          <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Patient decision</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Eligibility criteria not fulfilled</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="44"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set consisted of all randomised patients analysed on an intent to treat basis.</population>
      <group_list>
        <group group_id="B1">
          <title>Olaparib 300 mg Twice Daily (bd)</title>
          <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</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="92"/>
            <count group_id="B2" value="62"/>
            <count group_id="B3" value="154"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.2" spread="10.27"/>
                    <measurement group_id="B2" value="56.4" spread="9.07"/>
                    <measurement group_id="B3" value="57.5" spread="9.81"/>
                  </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="39"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="84"/>
                  </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="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="148"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </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="5"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="141"/>
                  </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="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)</title>
        <description>To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)</title>
          <description>To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.</description>
          <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</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="92"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" lower_limit="4.14" upper_limit="11.01"/>
                    <measurement group_id="O2" value="3.8" lower_limit="3.52" upper_limit="4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0038</p_value>
            <method>Log-rank test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.531</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.346</ci_lower_limit>
            <ci_upper_limit>0.815</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.</description>
        <time_frame>Upto 4 years</time_frame>
        <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.</description>
          <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</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="92"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" lower_limit="15.28" upper_limit="26.32"/>
                    <measurement group_id="O2" value="19.2" lower_limit="14.32" upper_limit="26.12"/>
                  </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>0.3487</p_value>
            <method>Log-rank test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.831</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.564</ci_lower_limit>
            <ci_upper_limit>1.224</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomisation to Second Progression (PFS2)</title>
        <description>To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomisation to Second Progression (PFS2)</title>
          <description>To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.</description>
          <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</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="92"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" lower_limit="8.21" upper_limit="23.85"/>
                    <measurement group_id="O2" value="9.3" lower_limit="8.15" upper_limit="13.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0613</p_value>
            <method>Log-rank test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.659</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.426</ci_lower_limit>
            <ci_upper_limit>1.020</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomisation to Second Subsequent Therapy or Death (TSST)</title>
        <description>To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomisation to Second Subsequent Therapy or Death (TSST)</title>
          <description>To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.</description>
          <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</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="92"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.9" lower_limit="9.13" upper_limit="19.78"/>
                    <measurement group_id="O2" value="9.6" lower_limit="8.34" upper_limit="12.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0111</p_value>
            <method>Log-rank test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.611</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.418</ci_lower_limit>
            <ci_upper_limit>0.894</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomisation to First Subsequent Therapy or Death (TFST)</title>
        <description>To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomisation to First Subsequent Therapy or Death (TFST)</title>
          <description>To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.</description>
          <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</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="92"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="6.21" upper_limit="12.85"/>
                    <measurement group_id="O2" value="5.4" lower_limit="3.94" upper_limit="6.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Log-rank test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.442</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.297</ci_lower_limit>
            <ci_upper_limit>0.658</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Randomisation to Study Treatment Discontinuation or Death (TDT)</title>
        <description>To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Randomisation to Study Treatment Discontinuation or Death (TDT)</title>
          <description>To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.</description>
          <population>Intention to treat (ITT): All randomised patients, Myriad confirmed Breast cancer susceptibility gene mutation (gBRCAm) subgroup.</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="92"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="5.52" upper_limit="10.97"/>
                    <measurement group_id="O2" value="3.8" lower_limit="3.61" upper_limit="4.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Log-rank test</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.425</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.289</ci_lower_limit>
            <ci_upper_limit>0.627</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1</title>
        <description>To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.</description>
        <time_frame>Up to 4 years</time_frame>
        <population>All randomised patients with measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1</title>
          <description>To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.</description>
          <population>All randomised patients 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="72"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3273</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.520</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.668</ci_lower_limit>
            <ci_upper_limit>3.610</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1</title>
        <description>Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.</description>
        <time_frame>At 16 weeks</time_frame>
        <population>Intention to treat (ITT): All randomised patients</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1</title>
          <description>Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.</description>
          <population>Intention to treat (ITT): All randomised patients</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not evaluable/missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire</title>
        <description>To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.&#xD;
A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.&#xD;
bd twice daily.</description>
        <time_frame>From baseline up to 6 months</time_frame>
        <population>Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire</title>
          <description>To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.&#xD;
A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.&#xD;
bd twice daily.</description>
          <population>Patient reported outcome (PRO) analysis set was defined as the analysis population for PRO data were a subset of the FAS (ITT) population who had evaluable baseline EORTC QLQ-C30 or QLQ-PAN26 forms where evaluable meant that at least 1 sub-scale baseline score could be determined from at least 1 of the 2 forms.</population>
          <units>Unit on scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.03" lower_limit="-3.826" upper_limit="1.759"/>
                    <measurement group_id="O2" value="1.18" lower_limit="-2.585" upper_limit="4.939"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.355</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.917</ci_lower_limit>
            <ci_upper_limit>2.496</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs)</title>
        <description>To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events</description>
        <time_frame>Up to 4 years</time_frame>
        <population>Safety Analysis Set consisted of all patients who received at least one dose of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Olaparib 300 mg Twice Daily (bd)</title>
            <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs)</title>
          <description>To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events</description>
          <population>Safety Analysis Set consisted of all patients who received at least one dose of study treatment.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE of CTCAE Grade 3 or higher</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE with outcome = 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>Any SAE (including events with outcome = death)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AnyAE leading to withdrawal of olaparib/placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE leading to dose interruption</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE leading to dose reduction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From informed consent until 30 days after last dose + subsequent treatment-related events reported (maximum up to 4 years).</time_frame>
      <desc>Only 90 patients in Olaparib and 61 patients in Placebo group were reported for safety because 3 patients did not receive study treatment and were not reported in the safety table.</desc>
      <group_list>
        <group group_id="E1">
          <title>Olaparib 300 mg Twice Daily (bd)</title>
          <description>Randomised participants received orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Randomised participants received placebo tablets orally 300 mg bd which were made up of 2 x 150 mg tablets bd with 100 mg tablets used to manage dose reductions.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 21.1</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="68" subjects_at_risk="92"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="61"/>
              </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="7" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Duodenal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Gastric varices haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Obstruction gastric</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Bartholinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Incisional hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </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="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder papilloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Stent malfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA version 21.1</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="89" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="35" subjects_affected="26" subjects_at_risk="90"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="66" subjects_affected="44" subjects_at_risk="90"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="49" subjects_affected="34" subjects_at_risk="90"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="39" subjects_affected="26" subjects_at_risk="90"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="33" subjects_affected="25" subjects_at_risk="90"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="49" subjects_affected="23" subjects_at_risk="90"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="90"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="9" subjects_at_risk="90"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="47" subjects_affected="42" subjects_at_risk="90"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="16" subjects_at_risk="90"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="17" subjects_at_risk="90"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="21" subjects_affected="12" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="16" subjects_affected="10" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="14" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="12" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="90"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="16" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="29" subjects_affected="24" subjects_at_risk="90"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="60"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="28" subjects_affected="24" subjects_at_risk="90"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="25" subjects_affected="19" subjects_at_risk="90"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="90"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="13" subjects_affected="9" subjects_at_risk="90"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="15" subjects_affected="12" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="61"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="90"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="61"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="12" subjects_affected="5" subjects_at_risk="90"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="61"/>
              </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>This submission /document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Leader</name_or_title>
      <organization>AstraZeneca AB</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/NCT02184195
org study id: D081FC00001
secondary id: 2014-001589-85
nct id: NCT02184195
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance
      Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose
      Disease Has Not Progressed on First Line Platinum Based Chemotherapy
Approximately 145 patients will be randomised using an Interactive Voice Response System
      /Interactive Web Response System (IVR/IWR system) in a 3:2 ratio (Olaparib:placebo) to the
      treatments as specified below:

        -  Olaparib tablets p.o. 300 mg twice daily

        -  Matching placebo tablets p.o. twice daily Eligible patients will be those patients with
           pancreas cancer previously treated for metastatic disease who have not progressed
           following completion of at least 16 weeks (can be more) of first line platinum-based
           chemotherapy. All patients must have a known deleterious or suspected deleterious
           germline BRCA mutation to be randomised; this may have been determined prior to
           enrolment into the study or may be assessed as part of the enrolment procedure for the
           study (via centrally provided MyriadIntegrated BRAC.

      Patients will be randomised within 6 weeks after their last dose of chemotherapy (last dose
      is the day of the last infusion) and treatment started as soon as possible but no less than 4
      and no more than 8 weeks of the last chemotherapy dose. At the time of starting protocol
      treatment, all previous chemotherapy treatment should be discontinued.

      Following randomisation, patients will attend clinic visits weekly for the first 4 weeks of
      treatment (Days 8, 15, 22 and 29). Patients will then attend clinic visits every 4 weeks
      whilst on study treatment. Patients should continue to receive study treatment until
      objective radiological disease progression as per RECIST as assessed by the investigator and
      as long as in the investigator's opinion they are benefiting from treatment and they do not
      meet any other discontinuation criteria.

      Once a patient has progressed the patient will be followed for second progression (PFS2)
      every 8 weeks and then survival until the final analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression-free Survival (PFS) by Blinded Independent Central Review (BICR) Using Modified Response Evaluation Criteria in Solid Tumours. This Study Used Modified RECIST Version (v) 1.1 (RECIST v1.1)
time frame: Up to 4 years
description: To determine the efficacy of olaparib maintenance monotherapy compared to placebo by PFS. The PFS was defined as the time from randomisation until the date of objective radiological disease progression according to modified RECIST v1.1 or death (by any cause in the absence of disease progression) regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to disease progression.
measure: Overall Survival (OS)
time frame: Upto 4 years
description: To determine the efficacy by assessment of OS of olaparib maintenance monotherapy compared to placebo. The OS was defined as the time from the date of randomization until death due to any cause.
measure: Time From Randomisation to Second Progression (PFS2)
time frame: Up to 4 years
description: To determine efficacy by assessment of PFS2 of olaparib maintenance monotherapy compared to placebo. The PFS2 was defined as the time from the date of randomisation to the earliest of the progression event subsequent to that used for the primary variable PFS or death.
measure: Time From Randomisation to Second Subsequent Therapy or Death (TSST)
time frame: Up to 4 years
description: To determine the efficacy by assessment of TSST of olaparib maintenance monotherapy compared to placebo. The TSST was defined as time to second subsequent therapy or death.
measure: Time From Randomisation to First Subsequent Therapy or Death (TFST)
time frame: Up to 4 years
description: To determine the efficacy by assessment of TFST of olaparib maintenance monotherapy compared to placebo. The TFST was defined as time to first subsequent therapy or death.
measure: Time From Randomisation to Study Treatment Discontinuation or Death (TDT)
time frame: Up to 4 years
description: To determine the efficacy by assessment of TDT compared to placebo. compared to placebo. The TDT was defined as time to study treatment discontinuation or death.
measure: Number of Participants With Objective Response Rate (ORR) by BICR Using Modified RECIST 1.1
time frame: Up to 4 years
description: To determine efficacy by assessment of objective response rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo. The ORR is defined as the number of with a BoR of CR and PR according to the BICR data divided by the number of patients in the treatment group with measurable disease at baseline.
measure: Disease Control Rate (DCR) by BICR Using Modified RECIST 1.1
time frame: At 16 weeks
description: Efficacy by assessment of disease control rate according to modified RECIST 1.1 of olaparib maintenance monotherapy compared to placebo.
measure: Adjusted Mean Change From Baseline up to 6 Months in Global Quality of Life (QoL) Score From the EORTC-QLQ-C30 Questionnaire
time frame: From baseline up to 6 months
description: To assess the effect of olaparib on health-related quality of life (QoL) as measured by the EORTC-QLQ-C30 global QoL scale. The EORTC-QLQ-C30 is defined as EORTC QLQ-C30: a questionnaire (30 questions) used to evaluate disease symptoms, functional impacts (eg, physical functioning), and HRQoL and to characterize clinical benefit from the patient perspective. The HRQoL score ranges from 0 to 100.
A higher score indicates better QoL. A score change of 10 points was pre-defined as clinically meaningful.
bd twice daily.
measure: Number of Participants With Adverse Events (AEs)
time frame: Up to 4 years
description: To assess the safety and tolerability of olaparib maintenance monotherapy. SAE: serious adverse events CTCAE: Common Terminology Criteria for Adverse Events
arm group label: Olaparib
arm group type: Experimental
description: Olaparib tablets po. 300 mg twice daily
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo tablets twice daily
intervention type: Drug
intervention name: Olaparib
description: Tablet -100mg
arm group label: Olaparib
intervention type: Drug
intervention name: Olaparib
description: Tablet-150mg
arm group label: Olaparib
intervention type: Drug
intervention name: Placebo
description: Match Olaparib 100mg placebo
arm group label: Placebo
intervention type: Drug
intervention name: Placebo
description: Match Olaparib 150mg placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
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country: Australia
country: Belgium
country: Canada
country: France
country: Germany
country: Israel
country: Italy
country: Korea, Republic of
country: Netherlands
country: Spain
country: United Kingdom
country: United States
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D081FC00001&amp;attachmentIdentifier=9095e288-3d26-4c56-87dd-5dedc61f25c2&amp;fileName=POLO_Revised_CSP_2-24Jul2019_Redacted.pdf&amp;versionIdentifier=
description: Related Info
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D081FC00001&amp;attachmentIdentifier=42f897a4-b682-4a0f-b2b0-cecf3f143423&amp;fileName=D081FC00001_Redacted_SAP.pdf&amp;versionIdentifier=
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description: Related Info
citation: Golan T, Hammel P, Reni M, Van Cutsem E, Macarulla T, Hall MJ, Park JO, Hochhauser D, Arnold D, Oh DY, Reinacher-Schick A, Tortora G, Algul H, O'Reilly EM, McGuinness D, Cui KY, Schlienger K, Locker GY, Kindler HL. Maintenance Olaparib for Germline BRCA-Mutated Metastatic Pancreatic Cancer. N Engl J Med. 2019 Jul 25;381(4):317-327. doi: 10.1056/NEJMoa1903387. Epub 2019 Jun 2.
PMID: 31157963
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Pancreatic Neoplasms
mesh term: Olaparib
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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