<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/NCT02993731</url>
  </required_header>
  <id_info>
    <org_study_id>CanStem111P</org_study_id>
    <nct_id>NCT02993731</nct_id>
  </id_info>
  <brief_title>A Study of Napabucasin Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma</brief_title>
  <acronym>CanStem111P</acronym>
  <official_title>A Phase III Study of BBI-608 Plus Nab-Paclitaxel With Gemcitabine in Adult Patients With Metastatic Pancreatic Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sumitomo Pharma Oncology, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sumitomo Pharma Oncology, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly&#xD;
      nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult&#xD;
      patients with Metastatic Pancreatic Ductal Adenocarcinoma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">March 2020</completion_date>
  <primary_completion_date type="Actual">March 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.</time_frame>
    <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
    <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
    <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
    <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma. ORR is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Adverse Events</measure>
    <time_frame>Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.</time_frame>
    <description>All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.</measure>
    <time_frame>8 weeks</time_frame>
    <description>QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. EORTQ QLC-C30 is a questionnaire used to assess the overall quality of life in cancer patients - 28 questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall Survival in Biomarker Positive Patients</measure>
    <time_frame>From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.</time_frame>
    <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
  </other_outcome>
  <other_outcome>
    <measure>Progression Free Survival in Biomarker Positive Patients</measure>
    <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
    <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
  </other_outcome>
  <other_outcome>
    <measure>Disease Control Rate in Biomarker Positive Patients</measure>
    <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
    <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. DCR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall Response Rate in Biomarker Positive Patients</measure>
    <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
    <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. ORR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1134</enrollment>
  <condition>Carcinoma, Pancreatic Ductal</condition>
  <arm_group>
    <arm_group_label>Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomized to this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Nab-paclitaxel with Gemcitabine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to this arm will receive weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Napabucasin</intervention_name>
    <description>Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.</description>
    <arm_group_label>Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine</arm_group_label>
    <other_name>BBI-608</other_name>
    <other_name>BBI608</other_name>
    <other_name>BB608</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nab-paclitaxel</intervention_name>
    <description>Nab-paclitaxel 125 mg/m^2 immediately followed by gemcitabine 1000 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.</description>
    <arm_group_label>Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine</arm_group_label>
    <arm_group_label>Arm 2: Nab-paclitaxel with Gemcitabine</arm_group_label>
    <other_name>Abraxane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Nab-paclitaxel 125 mg/m^2 immediately followed by gemcitabine 1000 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.</description>
    <arm_group_label>Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine</arm_group_label>
    <arm_group_label>Arm 2: Nab-paclitaxel with Gemcitabine</arm_group_label>
    <other_name>Gemzar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written, signed consent for trial participation must be obtained from the patient&#xD;
             appropriately in accordance with applicable International Conference on Harmonization&#xD;
             (ICH) guidelines and local and regulatory requirements prior to the performance of any&#xD;
             study specific procedure.&#xD;
&#xD;
          2. Must have histologically or cytologically confirmed advanced pancreatic ductal&#xD;
             adenocarcinoma (PDAC) that is metastatic. The definitive diagnosis of metastatic PDAC&#xD;
             will be made by integrating the histopathological data within the context of the&#xD;
             clinical and radiographic data. Patients with islet cell neoplasms are excluded.&#xD;
&#xD;
          3. Must not have previously received chemotherapy or any investigational agent for the&#xD;
             treatment of PDAC. A fluoropyrimidine or gemcitabine administered as a radiation&#xD;
             sensitizer in the adjuvant setting is allowed for as long as last dose was&#xD;
             administered &gt; 6 months prior to randomization and no lingering toxicities are&#xD;
             present.&#xD;
&#xD;
          4. Nab-paclitaxel with gemcitabine therapy is appropriate for the patient and recommended&#xD;
             by the Investigator.&#xD;
&#xD;
          5. Patient has one or more metastatic tumors evaluable by CT scan with contrast (or MRI,&#xD;
             if patient is allergic to CT contrast media) per RECIST 1.1. Imaging investigations&#xD;
             including CT/MRI of chest/abdomen/pelvis or other scans as necessary to document all&#xD;
             sites of disease must be performed within 14 days prior to randomization. Qualifying&#xD;
             scans performed as part of standard of care prior to patient signature of the study&#xD;
             informed consent will be acceptable as baseline scanning as long as scanning is&#xD;
             performed &lt; 14 days prior to randomization.&#xD;
&#xD;
          6. Must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1,&#xD;
             assessed within 14 days prior to randomization. Two observers qualified to perform&#xD;
             assessment of the performance status will be required to perform this assessment. If&#xD;
             discrepant, the one with the most deteriorated performance status will be considered&#xD;
             true.&#xD;
&#xD;
          7. Must have life-expectancy of &gt; 12 weeks.&#xD;
&#xD;
          8. Must be ≥ 18 years of age. Due to increased risk of sepsis in patients &gt;80 years old,&#xD;
             candidate patients in this age group should be thoroughly evaluated prior to study&#xD;
             randomization to ensure they are fit to receive chemotherapy. In addition to all of&#xD;
             the inclusion/exclusion criteria listed, clinical judgment should be used regarding&#xD;
             patients' susceptibility to infection (including but not limited to presence of&#xD;
             ascites or diabetes mellitus increasing risk of infection). Furthermore, the expected&#xD;
             stability of their performance status while receiving repeat weekly chemotherapy&#xD;
             cycles should be given special attention. Patients in this age group should not be&#xD;
             randomized on the study should there be any hesitation on any of these considerations.&#xD;
&#xD;
          9. For male or female patients of child producing potential: Must agree to use&#xD;
             contraception or take measures to avoid pregnancy during the study and for 180 days&#xD;
             after the final dose of nab-paclitaxel and gemcitabine or for 30 days for female&#xD;
             patients and for 90 days for male patients, after the final napabucasin dose if&#xD;
             nab-paclitaxel and gemcitabine were not administered.&#xD;
&#xD;
         10. Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy&#xD;
             test within 5 days prior to randomization.&#xD;
&#xD;
         11. Patient has adequate biological parameters as demonstrated by the following blood&#xD;
             counts at baseline (obtained &lt; 14 days prior to randomization; laboratory testing&#xD;
             performed as part of standard of care prior to patient signature of informed consent&#xD;
             for the study will be acceptable as baseline laboratory work as long as testing is&#xD;
             performed &lt; 14 days prior to randomization):&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) &gt; 1.5 x 10^9/L&#xD;
&#xD;
               2. Platelet count &gt; 100,000/mm^3 (100 x 10^9/L). Must not have required transfusion&#xD;
                  of platelets within 1 week of baseline platelet count assessment.&#xD;
&#xD;
               3. Hemoglobin (HgB) &gt; 9 g/dL. Must not have required transfusion of red blood cells&#xD;
                  within 1 week of baseline Hgb assessment.&#xD;
&#xD;
         12. Patient has the following blood chemistry levels at baseline (obtained &lt; 14 days prior&#xD;
             to randomization; laboratory testing performed as part of standard of care prior to&#xD;
             patient signature of informed consent for the study will be acceptable as baseline&#xD;
             laboratory work as long as testing is performed &lt; 14 days prior to randomization):&#xD;
&#xD;
               1. AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) [≤ 5&#xD;
                  × ULN in presence of liver metastases]&#xD;
&#xD;
               2. Total bilirubin ≤ 1.5 x institutional ULN. If total bilirubin is &gt; ULN and &lt; 1.5&#xD;
                  x ULN, it must be non-rising for at least 7 days.&#xD;
&#xD;
               3. Serum creatinine within normal limits or calculated clearance &gt; 60 mL/min/1.73&#xD;
                  m^2 for patients with serum creatinine levels above or below the institutional&#xD;
                  normal value. If using creatinine clearance, actual body weight should be used&#xD;
                  for calculating creatinine clearance (eg. Using the Cockcroft-Gault formula). For&#xD;
                  patients with a Body Mass Index (BMI) &gt; 30 kg/m^2, lean body weight should be&#xD;
                  used instead.&#xD;
&#xD;
         13. Patient not on anticoagulation has acceptable coagulation studies (obtained &lt; 14 days&#xD;
             prior to randomization; laboratory testing performed as part of standard of care prior&#xD;
             to patient signature of informed consent for the study will be acceptable as baseline&#xD;
             laboratory work as long as testing is performed &lt; 14 days prior to randomization) as&#xD;
             demonstrated by prothrombin time (PT) and partial thromboplastin time (PTT) below or&#xD;
             within normal limits (+15%).&#xD;
&#xD;
             Patients on anticoagulation must have coagulation values within the therapeutic range&#xD;
             appropriate for the anti-coagulation indication.&#xD;
&#xD;
         14. Patient has no clinically significant abnormalities on urinalysis results (obtained &lt;&#xD;
             14 days prior to randomization; laboratory testing performed as part of standard of&#xD;
             care prior to patient signature of informed consent for the study will be acceptable&#xD;
             as baseline laboratory work as long as testing is performed &lt; 14 days prior to&#xD;
             randomization).&#xD;
&#xD;
         15. Patient must have adequate nutritional status with Body Mass Index (BMI) &gt; 18 kg/m^2&#xD;
             and body weight of &gt; 40 kg with serum albumin &gt; 3 g/dL.&#xD;
&#xD;
         16. Baseline laboratory evaluations must be done within 14 days prior to randomization and&#xD;
             some must be repeated &lt; 72 hours prior to randomization.&#xD;
&#xD;
         17. Patients requiring biliary stent placement must have biliary stent placed &gt; 7 days&#xD;
             prior to screening.&#xD;
&#xD;
         18. Pain symptoms should be stable (of tolerable Grade 2 or less).&#xD;
&#xD;
         19. Only patients with available archival tumor tissue must consent to provision of, and&#xD;
             Investigator(s) must confirm access to and agree to submit a representative formalin&#xD;
             fixed paraffin block of tumor tissue in order that the specific correlative marker&#xD;
             assays (Correlative Studies) of this protocol may be conducted. Submission of the&#xD;
             tissue does not have to occur prior to randomization. Where local center regulations&#xD;
             prohibit submission of blocks of tumor tissue, two 2 mm cores of tumor from the block&#xD;
             and 5-20 unstained slides of whole sections of representative tumor tissue are&#xD;
             preferred. Where it is not possible to obtain two 2 mm cores of tumor from the block,&#xD;
             5-20 unstained slides of representative tumor tissue are also acceptable. Where no&#xD;
             previously resected or biopsied tumor tissue exists or is available, on the approval&#xD;
             of the Sponsor/designated CRO, the patient may still be considered eligible for the&#xD;
             study.&#xD;
&#xD;
         20. Patient must consent to provision of a sample of blood in order that the specific&#xD;
             correlative marker assays (Correlative Studies) may be conducted.&#xD;
&#xD;
         21. Patients must be accessible for treatment and follow up. Patients registered on this&#xD;
             trial must receive protocol treatment and be followed at the participating center.&#xD;
             This implies there must be reasonable geographical limits placed on patients being&#xD;
             considered for this trial. Investigators must ensure that the patients randomized on&#xD;
             this trial will be available for complete documentation of the treatment, response&#xD;
             assessment, adverse events, and follow-up.&#xD;
&#xD;
         22. Protocol treatment is to begin within 2 calendar days of patient randomization for&#xD;
             patients randomized to Arm 1. Patients randomized to Arm 2 must begin protocol&#xD;
             treatment within 7 calendar days of randomization.&#xD;
&#xD;
         23. The patient is not receiving therapy in a concurrent clinical study and the patient&#xD;
             agrees not to participate in other interventional clinical studies during their&#xD;
             participation in this trial while on study treatment. Patients participating in&#xD;
             surveys or observational studies are eligible to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with no evidence of metastatic disease as well as patients with a local&#xD;
             recurrence following surgical resection of primary lesion.&#xD;
&#xD;
          2. Patient has experienced a decline in ECOG performance status between Baseline visit&#xD;
             and within 72 hours prior to randomization.&#xD;
&#xD;
          3. Patient has a &gt; 20% decrease in serum albumin level between Baseline visit and within&#xD;
             72 hours prior to randomization.&#xD;
&#xD;
          4. Patient has a &gt; 10% decrease in weight between Baseline visit and within 72 hours&#xD;
             prior to randomization.&#xD;
&#xD;
          5. Any prior anti-cancer chemotherapy, biologic or investigational therapy for PDAC.&#xD;
&#xD;
               1. Patients receiving immunotherapy for non-cancer related treatment within &lt; 4&#xD;
                  weeks of first planned dose of study treatment will be excluded.&#xD;
&#xD;
               2. A fluoropyrimidine or gemcitabine administered as a radiation sensitizer in the&#xD;
                  adjuvant setting is allowed for as long as last dose was administered &gt; 6 months&#xD;
                  prior to randomization.&#xD;
&#xD;
          6. Major surgery within 4 weeks prior to randomization.&#xD;
&#xD;
          7. Any known brain or leptomeningeal metastases are excluded, even if treated.&#xD;
&#xD;
          8. Patients with clinically significant ascites or pleural effusions.&#xD;
&#xD;
          9. Women who are pregnant or breastfeeding. Women should not breastfeed while taking&#xD;
             study treatment and for 4 weeks after the last dose of napabucasin or while undergoing&#xD;
             treatment with nab-paclitaxel and gemcitabine and for 180 days after the last dose of&#xD;
             nab-paclitaxel and gemcitabine.&#xD;
&#xD;
         10. Gastrointestinal disorder(s) which, in the opinion of the Principal Investigator,&#xD;
             would significantly impede the absorption of an oral agent (e.g. active Crohn's&#xD;
             disease, ulcerative colitis, extensive gastric and small intestine resection).&#xD;
&#xD;
         11. Unable or unwilling to swallow napabucasin capsules daily.&#xD;
&#xD;
         12. Uncontrolled inter-current illness including, but not limited to, ongoing or active&#xD;
             infection, clinically significant non-healing or healing wounds, symptomatic&#xD;
             congestive heart failure, unstable angina pectoris, clinically significant cardiac&#xD;
             arrhythmia, significant pulmonary disease (shortness of breath at rest or mild&#xD;
             exertion), uncontrolled infection or psychiatric illness/social situations that would&#xD;
             limit compliance with study requirements.&#xD;
&#xD;
               1. History of cardiac disease: congestive heart failure (CHF) &gt; New York Heart&#xD;
                  Association (NYHA) Class II; active coronary artery disease, myocardial&#xD;
                  infarction or coronary stenting within 6 months prior to randomization;&#xD;
                  unevaluated new onset angina within 3 months or unstable angina (angina symptoms&#xD;
                  at rest) or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers&#xD;
                  or digoxin are permitted).&#xD;
&#xD;
               2. Current uncontrolled hypertension (systolic blood pressure [BP] &gt; 150 mmHg or&#xD;
                  diastolic pressure &gt; 90 mmHg despite optimal medical management) as well as prior&#xD;
                  history of hypertensive crisis or hypertensive encephalopathy.&#xD;
&#xD;
               3. Significant vascular disease (e.g., aortic aneurysm, aortic dissection,&#xD;
                  symptomatic peripheral vascular disease including claudication, Leo Buerger's&#xD;
                  disease). Treated peripheral vascular disease that is stable for at least 6&#xD;
                  months is allowed.&#xD;
&#xD;
               4. Evidence of bleeding diathesis or clinically significant coagulopathy.&#xD;
&#xD;
               5. Major surgical procedure (including open biopsy, significant traumatic injury,&#xD;
                  etc.) within 28 days, or anticipation of the need for major surgical procedure&#xD;
                  during the course of the study as well as minor surgical procedure (excluding&#xD;
                  placement of a vascular access device or bone marrow biopsy) within 7 days prior&#xD;
                  to randomization.&#xD;
&#xD;
               6. Patients with clinically significant abnormalities on urinalysis at &lt; 14 days&#xD;
                  prior to randomization.&#xD;
&#xD;
               7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal&#xD;
                  abscess within 6 months prior to randomization.&#xD;
&#xD;
               8. Ongoing serious, non-healing wound, ulcer, or bone fracture.&#xD;
&#xD;
               9. Known infection with Human Immunodeficiency Virus (HIV), and/or active infection&#xD;
                  with hepatitis B, or hepatitis C.&#xD;
&#xD;
              10. History of interstitial lung disease, history of slowly progressive dyspnea and&#xD;
                  unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis,&#xD;
                  pulmonary hypersensitivity pneumonitis or multiple allergies.&#xD;
&#xD;
              11. History of hemolytic-uremic syndrome.&#xD;
&#xD;
              12. History of connective tissue disorders (eg, lupus, scleroderma, arteritis&#xD;
                  nodosa).&#xD;
&#xD;
              13. Serious medical risk factors involving any of the major organ systems, or serious&#xD;
                  psychiatric disorders that could compromise the patient's safety or the study&#xD;
                  data integrity.&#xD;
&#xD;
         13. Known hypersensitivity to gemcitabine, taxanes or any of their excipients, or the&#xD;
             patient exhibits any of the events outlined in the Contraindications or Special&#xD;
             Warnings and Precautions sections of the product or comparator Summary of Product&#xD;
             Characteristics or Prescribing Information. Possible hypersensitivity to napabucasin&#xD;
             or one of the excipients which include the azo dyes sunset yellow and allura red.&#xD;
&#xD;
         14. Neurosensory neuropathy &gt; grade 2 at baseline.&#xD;
&#xD;
         15. Uncontrolled chronic diarrhea &gt; grade 2 at baseline.&#xD;
&#xD;
         16. Patients being treated with Warfarin.&#xD;
&#xD;
         17. Patients with active, uncontrolled bacterial, viral or fungal infection(s) requiring&#xD;
             systemic therapy&#xD;
&#xD;
         18. Patients with a history of other malignancies except: adequately treated non-melanoma&#xD;
             skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors&#xD;
             curatively treated by surgery alone or surgery plus radiotherapy with no evidence of&#xD;
             disease continuously for &gt; 5 years.&#xD;
&#xD;
         19. Any active disease condition which would render the protocol treatment dangerous or&#xD;
             impair the ability of the patient to receive protocol therapy.&#xD;
&#xD;
         20. Any condition (e.g. psychological, geographical, etc.) that does not permit compliance&#xD;
             with the protocol, including patients with history of poor compliance or history of&#xD;
             drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere&#xD;
             with the ability to comply with the study protocol. Patients planning to take a&#xD;
             vacation for 14 or more consecutive days during the course of the study are&#xD;
             ineligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UAB Comprehensive Cancer Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clearview Cancer Institute (CCI)</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highlands Oncology Group</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Blood and Cancer Center</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles Hematology Oncology Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Hospital of Orange</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Health Association DBA Torrance Memorial</name>
      <address>
        <city>Redondo Beach</city>
        <state>California</state>
        <zip>90277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Center Santa Monica Hematology And Oncology</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404-2125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Vallejo Medical Center</name>
      <address>
        <city>Vallejo</city>
        <state>California</state>
        <zip>94589-2441</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwalk Hospital The C Anthony and Jean Whittingham Cancer Center</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06850-3852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The C Anthony and Jean Whittingham Cancer Center</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06850-3852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helen F. Graham Cancer Center</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgetown University Medical Center (GUMC)</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists &amp; Research Institute</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Regional Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Cancer Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Specialists of North Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sylvester Comprehensive Cancer Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UF Health Cancer Center - Orlando Health</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists North</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists East Region</name>
      <address>
        <city>Wellington</city>
        <state>Florida</state>
        <zip>33414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Cancer &amp; Blood Center</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winship Cancer Institute of Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Regional Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Health System</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health Systems</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ingalls Cancer Research Center</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center CCOP</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine Regional Medical Group</name>
      <address>
        <city>Warrenville</city>
        <state>Illinois</state>
        <zip>60555-3269</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Physician Group (PPG)</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University - Melvin and Bren Simon Cancer</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cotton O'Neil Cancer Center</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana Hematology Oncology Associates (LHOA)</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Center for Cancer Medicine - Scarborough</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074-7171</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Baltimore Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital of Duluth</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro MN Clinical Oncology Research Consortium</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Oncology Associates</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Missouri - Ellis Fischel Cancer Cent</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCA Midwest Division (Kansas City)</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-1032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic - Cancer &amp; Hematology</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Frontier Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Englewood Hospital and Medical Center</name>
      <address>
        <city>Englewood</city>
        <state>New Jersey</state>
        <zip>07631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNM Cancer Research and Treatment Center</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Juan Oncology Associates</name>
      <address>
        <city>Farmington</city>
        <state>New Mexico</state>
        <zip>87401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Cancer Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Basset Medical Center</name>
      <address>
        <city>Cooperstown</city>
        <state>New York</state>
        <zip>13326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Hematology Oncology Associates PC</name>
      <address>
        <city>East Setauket</city>
        <state>New York</state>
        <zip>11733</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Associates of Central New York</name>
      <address>
        <city>East Syracuse</city>
        <state>New York</state>
        <zip>13057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Alliance</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine/ NewYork-Presbyterian</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stony Brook University</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Chapel Hill / Lineberger Comprehensive Cancer</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Medical Oncology Center</name>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <zip>27534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cone Health Cancer Center</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FirstHealth Outpatient Cancer Center</name>
      <address>
        <city>Pinehurst</city>
        <state>North Carolina</state>
        <zip>28374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Hospital</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gabrail Cancer Center (GCC) - Canton Facility</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic Cancer Centers</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623-3536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Southwest Oklahoma</name>
      <address>
        <city>Lawton</city>
        <state>Oklahoma</state>
        <zip>73505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic Oncology and Hematology - McAuley</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Westside Medical Office</name>
      <address>
        <city>Hillsboro</city>
        <state>Oregon</state>
        <zip>97124-5806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OHSU Knight Cancer Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center (FCCC) - Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111-2434</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Hematology Oncology Associates</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina (MUSC)</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425-8900</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Cancer Center</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607-5253</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHS Cancer Institute</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avera Medical Group</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology Chattanooga</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SCRI - Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203-1625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Cancer and Blood Disorders</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours Cancer Institute Medical Oncology</name>
      <address>
        <city>Midlothian</city>
        <state>Virginia</state>
        <zip>23114-3203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Institute</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology and Hematology Associates of Southwest Virginia</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Everett Clinic</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MultiCare Institute for Research and Innovation</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Mary Babb Randolph Cancer Center (MBRCC)</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HSHS St. Vincent Hospital Regional Cancer Center</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Green Bay Oncology, Ltd. - West Green Bay</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora St. Luke's Medical Center - Vince Lombardi</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215-4330</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Border Medical Oncology</name>
      <address>
        <city>East Albury</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie University Hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICON Cancer Care</name>
      <address>
        <city>South Brisbane</city>
        <state>South Australia</state>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabrini Hospital</name>
      <address>
        <city>Malvern</city>
        <state>Victoria</state>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blacktown Cancer and Haematology Centre</name>
      <address>
        <city>Blacktown</city>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Border Medical Oncology</name>
      <address>
        <city>East Albury</city>
        <zip>2640</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Austin Hospital</name>
      <address>
        <city>Heidelberg</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabrini Hospital</name>
      <address>
        <city>Malvern</city>
        <zip>3144</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Charles Gairdner Hospital</name>
      <address>
        <city>Nedlands</city>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prince of Wales Private Hospital</name>
      <address>
        <city>Randwick</city>
        <zip>2031</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICON Cancer Care</name>
      <address>
        <city>South Brisbane</city>
        <zip>4101</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macquarie University Hospital</name>
      <address>
        <city>Sydney</city>
        <zip>2109</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Tweed Hospital</name>
      <address>
        <city>Tweed Heads</city>
        <zip>2485</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sydney Adventist Hospital</name>
      <address>
        <city>Wahroonga</city>
        <zip>2076</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH Universitätsklinikum Graz</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Medical University Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Feldkirch</name>
      <address>
        <city>Rankweil</city>
        <zip>6830</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinik far Innere Medizin III</name>
      <address>
        <city>Salzburg</city>
        <zip>5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ULB Erasme</name>
      <address>
        <city>Bruxelles</city>
        <zip>13-1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <zip>B-2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Ghent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Liege</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dinant Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Everett Chalmers Regional Hospital</name>
      <address>
        <city>Fredericton</city>
        <state>New Brunswick</state>
        <zip>E3B 5N5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Atlantic Clinical Cancer Research Unit (ACCRU)</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 1C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de St. Mary</name>
      <address>
        <city>Pointe-Claire</city>
        <state>Quebec</state>
        <zip>H9R 2Y2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ciusssmcq</name>
      <address>
        <city>Trois-Rivières</city>
        <state>Quebec</state>
        <zip>G8Z 3R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Toronto - St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first hospital of jilin university</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510095</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <zip>510180</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Shaw Hospital School of Medicine Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Medical University Cancer Hospital</name>
      <address>
        <city>Harbin</city>
        <zip>150000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <zip>230022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Anhui Medical University</name>
      <address>
        <city>Hefei</city>
        <zip>230601</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The 81 Hospital of the Chinese Peoples Liberation Army</name>
      <address>
        <city>Nanjing</city>
        <zip>210002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Cancer Hospital</name>
      <address>
        <city>Nanjing</city>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <zip>266061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huashan Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ren Ji Hospital Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <zip>200120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Hospital of Tongji University</name>
      <address>
        <city>Shanghai</city>
        <zip>200123</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <zip>215006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
      <address>
        <city>Tianjin</city>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xian Jiao Tong University</name>
      <address>
        <city>Xian</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Ningxia Medical University</name>
      <address>
        <city>Yinchuan</city>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <zip>450008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologicke oddeleni</name>
      <address>
        <city>Benešov</city>
        <zip>25601</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Brno Interni hematoonkologicka klinika</name>
      <address>
        <city>Brno</city>
        <zip>62500</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>50005</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>77906</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologické oddělení</name>
      <address>
        <city>Zlín</city>
        <zip>762 75</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Sud - CHU Amiens Picardie</name>
      <address>
        <city>Amiens</city>
        <zip>80054</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Trousseau, CHRU de Tours</name>
      <address>
        <city>Chambray-lès-Tours</city>
        <zip>37170</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Edourard Herriot</name>
      <address>
        <city>Lyon Cedex 03</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU-Hôtel Dieu</name>
      <address>
        <city>Nantes Cedex 1</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Poitiers University Hospital</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Eugene Marquis</name>
      <address>
        <city>Rennes</city>
        <zip>35042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Anne</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Civil de strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute de Cancerologie de Lorraine</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gesundheitszentrum St. Marien GmbH</name>
      <address>
        <city>Amberg</city>
        <zip>92224</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Bonn</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus Nordwest</name>
      <address>
        <city>Frankfurt am main</city>
        <zip>60488</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SLK-Kliniken Heilbronn GmbH</name>
      <address>
        <city>Heilbronn</city>
        <zip>74078</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsmedizin Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Bogenhausen</name>
      <address>
        <city>München</city>
        <zip>81925</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Oldenburg AöR - UK für Innere Medizin</name>
      <address>
        <city>Oldenburg</city>
        <zip>26133</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Poliambulanza</name>
      <address>
        <city>Brescia</city>
        <zip>25124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Ricerca e la Cura del Cancro (IRCC)</name>
      <address>
        <city>Candiolo</city>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Mater Domini</name>
      <address>
        <city>Catanzaro</city>
        <zip>88200</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale degli Infermi</name>
      <address>
        <city>Faenza</city>
        <zip>48018</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Maria de Prato Hospital</name>
      <address>
        <city>Feltre</city>
        <zip>32032</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS - Studio e la Cura dei Tumori</name>
      <address>
        <city>Meldola</city>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospedale San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AO SM Misericordia</name>
      <address>
        <city>Perugia</city>
        <zip>06132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliera S.Maria Nuova</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale degli Infermi</name>
      <address>
        <city>Rimini</city>
        <zip>47923</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dermatological Hospital San Lazzaro</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Settelaghi</name>
      <address>
        <city>Varese</city>
        <zip>21100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>241-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tochigi Cancer Center</name>
      <address>
        <city>Utsunomiya</city>
        <state>Tochigi</state>
        <zip>320-0834</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tokyo Hospital</name>
      <address>
        <city>Bunkyō-Ku</city>
        <state>Tokyo</state>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital Of JFCR</name>
      <address>
        <city>Koto-Ku</city>
        <state>Tokyo</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyorin University Hopsital</name>
      <address>
        <city>Mitaka</city>
        <state>Tokyo</state>
        <zip>181-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Saitama</city>
        <zip>362-0806</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul national University Bundang Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Jeongnam</city>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul St. Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06591</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden (MCL)</name>
      <address>
        <city>Leeuwarden</city>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medical Center</name>
      <address>
        <city>Sittard</city>
        <zip>6162 BG</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isala Ziekenhuis</name>
      <address>
        <city>Zwolle</city>
        <zip>8025 AB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne</name>
      <address>
        <city>Gdańsk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii-Instytut im.M.Sklodowskiej-Curie</name>
      <address>
        <city>Gliwice</city>
        <zip>44-101</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Przychodnia Lekarska KOMED</name>
      <address>
        <city>Konin</city>
        <zip>62-500</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Chirurgii Onkologicznej</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii Ziemi Lubelskiej</name>
      <address>
        <city>Lublin</city>
        <zip>20-090</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny</name>
      <address>
        <city>Poznań</city>
        <zip>44-400</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Szpital Zespolony</name>
      <address>
        <city>Toruń</city>
        <zip>87-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundação Champalimaud</name>
      <address>
        <city>Lisboa</city>
        <zip>1400-038</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital da Luz</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Lisboa Norte</name>
      <address>
        <city>Lisbon</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto, E.P.E</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IPO Porto Francisco Gentil, E.P.E.</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Entre Douro e Vouga</name>
      <address>
        <city>Santa Maria Da Feira</city>
        <zip>4520-211</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kursk Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Kislino</city>
        <state>Kursk</state>
        <zip>305524</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkhangelsk Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Arkhangel'sk</city>
        <zip>163046</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republican Clinical Oncology Dispensary</name>
      <address>
        <city>Cheboksary</city>
        <zip>428020</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Llc Evimed</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Railway Clinical Hospital on station Chelyabinsk</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454091</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Republic Clinical Oncology Dispensary</name>
      <address>
        <city>Kazan</city>
        <zip>420029</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.N. Blokhin Russian Cancer Research Center</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privolzhsk District Medical Center</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603006</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Budgetary Healthcare Institution of Omsk Region</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orenburg Regional Clinical Oncology Dispensary</name>
      <address>
        <city>Orenburg</city>
        <zip>460021</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pyatigorsk Oncology Dispensary</name>
      <address>
        <city>Pyatigorsk</city>
        <zip>357502</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St.Petersburg Medical Universitet n.a. I.P. Pavlov</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197022</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Russian Research Centre of Radiology and Surgical Technologies&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Clinical Oncology Dispensary</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>198255</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multi-type clinic 'REAVIZ'</name>
      <address>
        <city>Samara</city>
        <zip>443011</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Research Mordovia State University</name>
      <address>
        <city>Saransk</city>
        <zip>430032</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169610</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d´Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico y Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>(ICO) Hospital Duran i Reynals</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Germans Trias i Pujol</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Gregorio Marañón</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral Oncologico Clara Campal</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Madrid</city>
        <zip>28220</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Alcorcon</name>
      <address>
        <city>Madrid</city>
        <zip>28922</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Málaga</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LinKou Chang Gung Memorial Hospital</name>
      <address>
        <city>Taoyuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zaytsev Institute General and Urgent Surgery of National Academy Medical Science of Ukraine</name>
      <address>
        <city>Kharkiv</city>
        <zip>61005</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Institute of Cancer</name>
      <address>
        <city>Kyiv</city>
        <zip>03022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>China</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>March 29, 2021</results_first_submitted>
  <results_first_submitted_qc>May 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 10, 2021</results_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Neoplasms</keyword>
  <keyword>Neoplasms by Site</keyword>
  <keyword>Digestive System Neoplasms</keyword>
  <keyword>Endocrine Gland Neoplasms</keyword>
  <keyword>Pancreatic Neoplasms</keyword>
  <keyword>Adenocarcinoma</keyword>
  <keyword>Neoplasms, Glandular and Epithelial</keyword>
  <keyword>Neoplasms by Histologic Type</keyword>
  <keyword>Digestive System Diseases</keyword>
  <keyword>Pancreatic Diseases</keyword>
  <keyword>Endocrine System Diseases</keyword>
  <keyword>Albumin-Bound Paclitaxel</keyword>
  <keyword>Gemcitabine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Carcinoma, Pancreatic Ductal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02993731/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT02993731/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>1134 participants were randomized between February 2017 and February 2019.</recruitment_details>
      <pre_assignment_details>Patients who died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine</title>
          <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Nab-paclitaxel With Gemcitabine</title>
          <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="565"/>
                <participants group_id="P2" count="569"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="464"/>
                <participants group_id="P2" count="464"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="105"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Termination</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="105"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine</title>
          <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Nab-paclitaxel With Gemcitabine</title>
          <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</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="565"/>
            <count group_id="B2" value="569"/>
            <count group_id="B3" value="1134"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="325"/>
                    <measurement group_id="B2" value="295"/>
                    <measurement group_id="B3" value="620"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="240"/>
                    <measurement group_id="B2" value="274"/>
                    <measurement group_id="B3" value="514"/>
                  </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="240"/>
                    <measurement group_id="B2" value="263"/>
                    <measurement group_id="B3" value="503"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="325"/>
                    <measurement group_id="B2" value="306"/>
                    <measurement group_id="B3" value="631"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="188"/>
                    <measurement group_id="B3" value="382"/>
                  </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="10"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="350"/>
                    <measurement group_id="B2" value="354"/>
                    <measurement group_id="B3" value="704"/>
                  </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="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Survival</title>
        <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma.</description>
        <time_frame>From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma.</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="565"/>
                <count group_id="O2" value="569"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.43" lower_limit="10.51" upper_limit="12.19"/>
                    <measurement group_id="O2" value="11.73" lower_limit="10.74" upper_limit="12.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival</title>
        <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.</description>
        <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="565"/>
                <count group_id="O2" value="569"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.70" lower_limit="5.68" upper_limit="7.26"/>
                    <measurement group_id="O2" value="6.08" lower_limit="5.59" upper_limit="7.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate</title>
        <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.</description>
        <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine (Response Analysis Set)</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and had measurable disease per RECIST 1.1 at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine (Response Analysis Set)</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and had measurable disease per RECIST 1.1 at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate</title>
          <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.</description>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="556"/>
                <count group_id="O2" value="559"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74" lower_limit="71" upper_limit="78"/>
                    <measurement group_id="O2" value="76" lower_limit="72" upper_limit="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate</title>
        <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma. ORR is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).</description>
        <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine (Response Analysis Set)</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and had measurable disease per RECIST 1.1 at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine (Response Analysis Set)</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and had measurable disease per RECIST 1.1 at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate</title>
          <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma. ORR is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).</description>
          <units>Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="556"/>
                <count group_id="O2" value="559"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43" lower_limit="39" upper_limit="47"/>
                    <measurement group_id="O2" value="43" lower_limit="39" upper_limit="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Adverse Events</title>
        <description>All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.</description>
        <time_frame>Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population)</title>
            <description>All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine (Safety Population)</title>
            <description>All participants who received at least 1 dose of nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Adverse Events</title>
          <description>All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="561"/>
                <count group_id="O2" value="547"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="560"/>
                    <measurement group_id="O2" value="543"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.</title>
        <description>QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. EORTQ QLC-C30 is a questionnaire used to assess the overall quality of life in cancer patients - 28 questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life.</description>
        <time_frame>8 weeks</time_frame>
        <population>Each patient has 1 score selected from questionnaires collected from scheduled and unscheduled visits per scale per analysis window. If a patient had more than 1 questionnaire collected in an analysis window, the one collected closest to the target day is selected; if questionnaires had same days from the target day, the later one is selected; if questionnaires collected from the same date, the worst one is selected.</population>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, and had at least one valid assessment at each analysis window.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, and had at least one valid assessment at each analysis window.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.</title>
          <description>QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. EORTQ QLC-C30 is a questionnaire used to assess the overall quality of life in cancer patients - 28 questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life.</description>
          <population>Each patient has 1 score selected from questionnaires collected from scheduled and unscheduled visits per scale per analysis window. If a patient had more than 1 questionnaire collected in an analysis window, the one collected closest to the target day is selected; if questionnaires had same days from the target day, the later one is selected; if questionnaires collected from the same date, the worst one is selected.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="420"/>
                <count group_id="O2" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.63" spread="22.535"/>
                    <measurement group_id="O2" value="-0.57" spread="23.402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Overall Survival in Biomarker Positive Patients</title>
        <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
        <time_frame>From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and were assessed to have positive pSTAT3 status based on their biomarker data.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and were assessed to have positive pSTAT3 status based on their biomarker data.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival in Biomarker Positive Patients</title>
          <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
          <units>Months</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.40" lower_limit="10.02" upper_limit="12.42"/>
                    <measurement group_id="O2" value="10.78" lower_limit="9.40" upper_limit="12.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Progression Free Survival in Biomarker Positive Patients</title>
        <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
        <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and were assessed to have positive pSTAT3 status based on their biomarker data.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine (pSTAT3 Positive)</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks and were assessed to have positive pSTAT3 status based on their biomarker data.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival in Biomarker Positive Patients</title>
          <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
                <count group_id="O2" value="176"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.68" lower_limit="5.49" upper_limit="7.39"/>
                    <measurement group_id="O2" value="5.82" lower_limit="5.55" upper_limit="7.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Disease Control Rate in Biomarker Positive Patients</title>
        <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. DCR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
        <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, were assessed to have positive pSTAT3 status based on their biomarker data and had measurable disease per RECIST 1.1 at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, were assessed to have positive pSTAT3 status based on their biomarker data and had measurable disease per RECIST 1.1 at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate in Biomarker Positive Patients</title>
          <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. DCR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
          <units>Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" lower_limit="69" upper_limit="81"/>
                    <measurement group_id="O2" value="79" lower_limit="72" upper_limit="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Overall Response Rate in Biomarker Positive Patients</title>
        <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. ORR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
        <time_frame>From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)</title>
            <description>All participants who were randomized to Arm 1 to receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, were assessed to have positive pSTAT3 status based on their biomarker data and had measurable disease per RECIST 1.1 at randomization.</description>
          </group>
          <group group_id="O2">
            <title>Nab-paclitaxel With Gemcitabine (pSTAT3 Positive; Response Analysis Set)</title>
            <description>All participants who were randomized to Arm 2 to receive nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks, were assessed to have positive pSTAT3 status based on their biomarker data and had measurable disease per RECIST 1.1 at randomization.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate in Biomarker Positive Patients</title>
          <description>To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. ORR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.</description>
          <units>Percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" lower_limit="35" upper_limit="49"/>
                    <measurement group_id="O2" value="47" lower_limit="40" upper_limit="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Napabucasin Plus Nab-paclitaxel With Gemcitabine (Safety Population)</title>
          <description>All participants who received at least 1 dose of napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Nab-paclitaxel With Gemcitabine (Safety Population)</title>
          <description>All participants who received at least 1 dose of nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="419" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="400" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="330" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="273" subjects_at_risk="547"/>
              </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="22" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Haemolytic uraemic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Thrombotic microangiopathy</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anaemia of chronic disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Haemolytic anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Splenic infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Splenic vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Acquired haemophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Pyloric stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Duodenal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Obstruction gastric</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Mechanical ileus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumoperitoneum</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Acute abdomen</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anal fissure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Diarrhoea haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastric perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hypomotility</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastrointestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Large intestinal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Malignant bowel obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Mesenteric vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pancreatic necrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Splenic artery aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Truncus coeliacus thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastrointestinal toxicity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Mallory-Weiss syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Neutropenic colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumatosis intestinalis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Device related thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Biliary dilatation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cholestasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gallbladder perforation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Haemobilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hepatic haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Liver abscess</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Arthritis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Biliary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Central nervous system infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Epstein-Barr virus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Escherichia pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hepatic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hepatitis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Klebsiella sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Lymphangitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Perihepatic abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumonia chlamydial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumonia klebsiella</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Retroperitoneal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Neutropenic infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pancreatic abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Peritonitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Prostate infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Splenic abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Streptococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Viral sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anastomotic complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Post procedural bile leak</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Postoperative hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Ankle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Chemical poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Bile output increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Influenza A virus test positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypoproteinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dupuytren's contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Muscle haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Metastases to liver</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Oncologic complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Metastases to peritoneum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pancreatic neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Papillary serous endometrial carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </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="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Diabetic neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypoglycaemic coma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Toxic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Axonal neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cerebral thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Lumbosacral plexopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Device extrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Nephropathy toxic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Nephrotic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Alveolitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Bronchopneumopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hydrothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Pancreaticoduodenectomy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Capillary leak syndrome</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Aneurysm ruptured</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Embolism venous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Trousseau's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Vena cava thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="560" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="543" subjects_at_risk="547"/>
              </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="306" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="318" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="145" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="165" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="105" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="126" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="410" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="213" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="329" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="252" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="250" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="162" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="215" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="124" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="194" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="209" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="211" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="203" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="205" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="189" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="179" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="180" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="143" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="137" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="138" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="155" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="120" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="137" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="111" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="143" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="93" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="85" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="88" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="57" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="547"/>
              </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="233" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="177" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="65" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="56" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="547"/>
              </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" subjects_affected="68" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="65" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="125" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="133" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="92" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="97" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="82" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="84" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chromaturia</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="69" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="68" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="74" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="52" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="55" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="212" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="210" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="89" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="85" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="547"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="561"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="547"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The primary author agrees to, prior to submitting a manuscript, abstract, or any other written/oral presentation describing the Results for publication/presentation, forward a copy to the Sponsor at least 45 days prior to their submission. The Sponsor may request an additional 30-day embargo. The Sponsor may require the primary author to delete any Confidential Information (other than the Clinical Results) and to require that any publication/presentation acknowledge the Sponsor's support.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Cindy Oh</name_or_title>
      <organization>Sumitomo Dainippon Pharma Oncology</organization>
      <phone>617-674-8628</phone>
      <email>coh@bostonbiomedical.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/NCT02993731
org study id: CanStem111P
nct id: NCT02993731
lead sponsor: 
has dmc: Yes
This is a randomized, open-label, multi-center, phase 3 study of napabucasin plus weekly
      nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine for adult
      patients with Metastatic Pancreatic Ductal Adenocarcinoma.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Survival
time frame: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
description: To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma.
measure: Progression Free Survival
time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
description: To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
measure: Disease Control Rate
time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
description: To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma. DCR is defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.
measure: Overall Response Rate
time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
description: To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma. ORR is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1).
measure: Number of Patients With Adverse Events
time frame: Every 1-2 weeks from date of screening until protocol treatment discontinuation. Following permanent protocol treatment discontinuation, every 8 weeks, starting with the 4 week post-protocol treatment discontinuation visit, up to 36 months.
description: All patients who have received at least one dose of napabucasin will be included in the safety analysis according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0. The incidence of adverse events will be summarized by type of adverse event and severity.
measure: Mean Change From Baseline for Global Quality of Life (QoL) at 8 Weeks.
time frame: 8 weeks
description: QoL will be measured using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ-C30) in patients with metastatic pancreatic ductal adenocarcinoma with napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine. EORTQ QLC-C30 is a questionnaire used to assess the overall quality of life in cancer patients - 28 questions use a 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions use a 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged and transformed to 0-100 scale; higher overall score = better quality of life.
measure: Overall Survival in Biomarker Positive Patients
time frame: From 4 weeks after the patient has been off study therapy, every 4 weeks thereafter for 6 months, then every 3 months thereafter until death, the study closes or 3 years since treatment discontinuation.
description: To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Survival of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
measure: Progression Free Survival in Biomarker Positive Patients
time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
description: To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Progression Free Survival (PFS) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. PFS is defined as the time from randomization to the first objective documentation of disease progression or death due to any cause. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
measure: Disease Control Rate in Biomarker Positive Patients
time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
description: To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Disease Control Rate (DCR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. DCR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
measure: Overall Response Rate in Biomarker Positive Patients
time frame: From date of randomization, every 8 weeks, until the date of first documented objective disease progression, up to 36 months
description: To assess the effect of napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine on the Overall Response Rate (ORR) of patients with metastatic pancreatic ductal adenocarcinoma in biomarker positive patients. ORR is evaluated using RECIST 1.1. This biomarker-positive sub-population is defined as those patients with phospho-STAT3 positivity based on immunohistochemical (IHC) staining of Formalin Fixed Paraffin Embedded (FFPE) tumor tissue.
arm group label: Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine
arm group type: Experimental
description: Patients randomized to this arm will receive napabucasin administered orally, twice daily in combination with weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
arm group label: Arm 2: Nab-paclitaxel with Gemcitabine
arm group type: Active Comparator
description: Patients randomized to this arm will receive weekly nab-paclitaxel and gemcitabine administered intravenously, once weekly, on 3 of every 4 weeks.
intervention type: Drug
intervention name: Napabucasin
description: Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.
arm group label: Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine
other name: BBI-608
other name: BBI608
other name: BB608
intervention type: Drug
intervention name: Nab-paclitaxel
description: Nab-paclitaxel 125 mg/m^2 immediately followed by gemcitabine 1000 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
arm group label: Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine
arm group label: Arm 2: Nab-paclitaxel with Gemcitabine
other name: Abraxane
intervention type: Drug
intervention name: Gemcitabine
description: Nab-paclitaxel 125 mg/m^2 immediately followed by gemcitabine 1000 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
arm group label: Arm 1: Napabucasin plus Nab-paclitaxel with Gemcitabine
arm group label: Arm 2: Nab-paclitaxel with Gemcitabine
other name: Gemzar
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: Australia
country: Austria
country: Belgium
country: Canada
country: China
country: Czechia
country: France
country: Germany
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Poland
country: Portugal
country: Russian Federation
country: Singapore
country: Spain
country: Taiwan
country: Ukraine
country: United States
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Carcinoma, Pancreatic Ductal
mesh term: Paclitaxel
mesh term: Gemcitabine
provided document: 
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reported events: 
certain agreements: 
point of contact: 