<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/NCT02250326</url>
  </required_header>
  <id_info>
    <org_study_id>ABI-007-NSCL-006</org_study_id>
    <secondary_id>2014-001105-41</secondary_id>
    <nct_id>NCT02250326</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of Nab®-Paclitaxel With CC-486 or Nab®-Paclitaxel With Durvalumab, and Nab®-Paclitaxel Monotherapy as Second/Third-line Treatment for Advanced Non-small Cell Lung Cancer</brief_title>
  <acronym>abound2L+</acronym>
  <official_title>A Phase 2, Open-Label, Multi-Center Study to Assess Safety and Efficacy of Second/Third-Line Treatment With NAB®-Paclitaxel (ABI-007) In Combination With Epigenetic Modifying Therapy Of CC-486, Or Immunotherapy of Durvalumab (MEDI4736), Or As Monotherapy In Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): Abound.2L+</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Celgene</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Celgene</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of&#xD;
      second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying&#xD;
      therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects&#xD;
      with advanced non-small cell lung cancer (NSCLC).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This Phase 2 study will test the hypothesis that epigenetic modifying therapy of CC-486 or&#xD;
      immunotherapy of durvalumab can improve the anti-tumor activity of nab-paclitaxel in subjects&#xD;
      with advanced non-small cell lung cancer (NSCLC) who have received no more than one prior&#xD;
      chemotherapy regimen for their advanced disease. It will further assess efficacy and safety&#xD;
      of nab-paclitaxel monotherapy in this setting. Each subject will receive study therapy as&#xD;
      second- or third-line of treatment. Approximately 240 male and female subjects with advanced&#xD;
      NSCLC will be assigned to one of the following treatment arms (approximately 80 subjects per&#xD;
      group): nab-paclitaxel /CC-486 combination therapy, nab-paclitaxel/durvalumab combination&#xD;
      therapy or nab-paclitaxel monotherapy prior to receiving first dose of Investigational&#xD;
      Product. A permuted-block randomization method will be employed to assign the subjects among&#xD;
      the treatment arms that are enrolling simultaneously, when applicable, stratified by the&#xD;
      following baseline factors: ECOG performance status (0 versus 1), gender (males versus&#xD;
      females), and smoker (yes versus no). Treatment assignments of subjects to the&#xD;
      nab-paclitaxel/CC-486 combination therapy and nab-paclitaxel monotherapy arms will be&#xD;
      conducted completely in a randomized fashion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 7, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">July 17, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator</measure>
    <time_frame>From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months</time_frame>
    <description>Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria</measure>
    <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
    <description>Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows:&#xD;
Complete Response is the disappearance of all target lesions;&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline;&#xD;
Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria</measure>
    <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
    <description>Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kaplan Meier Estimate of Overall Survival (OS)</measure>
    <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months</time_frame>
    <description>Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period</measure>
    <time_frame>TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 86.1 weeks</time_frame>
    <description>TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Discontinued Study Treatment</measure>
    <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
    <description>The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Intensity Per Week of Nab-Paclitaxel</measure>
    <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
    <description>Dose intensity was the cumulative dose divided by the dosing period in weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Intensity Per Week of CC-486</measure>
    <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
    <description>Dose intensity was the cumulative dose divided by the dosing period in weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Intensity Per Week of Durvalumab</measure>
    <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
    <description>Dose intensity was the cumulative dose divided by the dosing period in weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Study Drug Dose Reductions</measure>
    <time_frame>Up to 16 Jan 2017 for CC-486 + nab-paclitaxel and up to 23 Dec 2017 for nab-paclitaxel and Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
    <description>A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>Combination arm: nab-paclitaxel and CC-486</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the combination arm will receive nab-paclitaxel 100 mg^/m2 intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg orally daily (QD) on Days 1 to14 of each 21-day treatment cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monotherapy arm: nab-paclitaxel IV infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the monotherapy arm will receive nab-Paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day treatment cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nab-paclitaxel and Durvalumab combination</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects in the nab-Paclitaxel/durvalumab combination arm will receive nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and durvalumab 1125 mg IV infusion over approximately 1 hour on Day 15 of each 21-day treatment cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nab-paclitaxel IV</intervention_name>
    <description>nab-Paclitaxel intravenous (IV) infusion</description>
    <arm_group_label>Combination arm: nab-paclitaxel and CC-486</arm_group_label>
    <arm_group_label>Monotherapy arm: nab-paclitaxel IV infusion</arm_group_label>
    <arm_group_label>Nab-paclitaxel and Durvalumab combination</arm_group_label>
    <other_name>Abraxane</other_name>
    <other_name>ABI-007</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CC-486</intervention_name>
    <description>Oral CC-486</description>
    <arm_group_label>Combination arm: nab-paclitaxel and CC-486</arm_group_label>
    <other_name>Oral AZA</other_name>
    <other_name>Oral azacitidine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duravalumab</intervention_name>
    <arm_group_label>Nab-paclitaxel and Durvalumab combination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: 1.Age ≥ 18 years the time of signing the Informed Consent Form (ICF).&#xD;
&#xD;
        2. Understand and voluntarily provide written informed consent prior to the conduct of any&#xD;
        study related assessments/procedures.&#xD;
&#xD;
        3. Able to adhere to the study visit schedule and other protocol requirements. 4.&#xD;
        Histologically or cytologically confirmed advanced NSCLC who will receive study therapy as&#xD;
        second- or third-line of treatment for advanced disease.&#xD;
&#xD;
        5. No other current active malignancy requiring anticancer therapy. 6. Radiographically&#xD;
        documented measurable disease (defined by the presence of ≥ 1 radiographically documented&#xD;
        measurable lesion).&#xD;
&#xD;
        7. One prior platinum-containing chemotherapy for metastatic or recurrent NSCLC unless&#xD;
        patients are ineligible to receive it. Patients may have received no more than one line of&#xD;
        chemotherapy; immunotherapy in prior line of treatment (first or second line) is allowed.&#xD;
        Absolute neutrophil count (ANC) ≥ 1500 cells/mm3.&#xD;
&#xD;
        8. Platelets ≥ 100,000 cells/mm3. 9. Hemoglobin (Hgb) ≥ 9 g/dL. 10. Aspartate transaminase&#xD;
        (AST/serum glutamic oxaloacetic transaminase [SGOT]) and alanine transaminase (ALT/serum&#xD;
        glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × upper limit of normal range (ULN) or ≤ 5.0 ×&#xD;
        ULN if liver metastases.&#xD;
&#xD;
        11. Total bilirubin ≤ 1.5 ULN (unless there is a known history of Gilberts Syndrome).&#xD;
&#xD;
        12. Serum creatinine ≤ 1.5 x ULN, or calculated creatinine clearance ≥ 60 mL/min (if renal&#xD;
        impairment is suspected 24-hour urine collection for measurement is required).&#xD;
&#xD;
        13. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 14. Eastern&#xD;
        Cooperative Oncology Group (ECOG) performance status 0 or 1. 15. Females of childbearing&#xD;
        potential [defined as a sexually mature woman who (1) have not undergone hysterectomy (the&#xD;
        surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both&#xD;
        ovaries) or (2) have not been naturally postmenopausal for at least 24 consecutive months&#xD;
        (ie, has had menses at any time during the preceding 24 consecutive months)] must:&#xD;
&#xD;
          1. Have a negative pregnancy test (ß-hCG) as verified by the study doctor within 72 hours&#xD;
             prior to starting study therapy. She must agree to ongoing pregnancy testing during&#xD;
             the course of the study, and after end of study therapy. This applies even if the&#xD;
             subject practices true abstinence* from heterosexual contact.&#xD;
&#xD;
          2. Either commit to true abstinence* from heterosexual contact (which must be reviewed on&#xD;
             a monthly basis) or agree to use, and be able to comply with, effective contraception&#xD;
             without interruption, 28 days prior to starting investigational product (IP), during&#xD;
             the study therapy (including dose interruptions), and for 3 months after&#xD;
             discontinuation of study therapy.&#xD;
&#xD;
        Male subjects must:&#xD;
&#xD;
          1. Practice true abstinence* or agree to use a condom during sexual contact with a&#xD;
             pregnant female or a female of childbearing potential while participating in the&#xD;
             study, during dose interruptions and for at least 6 months following IP&#xD;
             discontinuation, even if he has undergone a successful vasectomy.&#xD;
&#xD;
          2. Refrain from semen or sperm donation while taking durvalumab and for at least 3 months&#xD;
             after the last dose of durvalumab.&#xD;
&#xD;
             16. Females must abstain from breastfeeding during study participation and 3 months&#xD;
             after IP discontinuation.&#xD;
&#xD;
             Exclusion Criteria:&#xD;
&#xD;
               -  The presence of any of the following will exclude a subject from enrollment:&#xD;
&#xD;
                    1. Refractory to prior taxane therapy for advanced disease. Prior taxane used&#xD;
                       in the adjuvant setting does not exclude eligibility, provided there is no&#xD;
                       disease recurrence within 12 months upon completion of chemotherapy in that&#xD;
                       setting.&#xD;
&#xD;
                    2. Evidence of active brain metastases, including leptomeningeal involvement&#xD;
                       (prior evidence of brain metastasis are permitted only if asymptomatic and&#xD;
                       clinically stable for at least 8 weeks following completion of therapy). MRI&#xD;
                       of the brain (or CT scan w/contrast) is preferred.&#xD;
&#xD;
                    3. Only evidence of disease is non-measurable at study entry.&#xD;
&#xD;
                    4. Known activating EGFR mutations (such as exon 19 deletions or L858R).&#xD;
&#xD;
                    5. Known activating EML4-ALK mutations.&#xD;
&#xD;
                    6. Preexisting peripheral neuropathy of Grade &gt; 2 (per NCI CTCAE v4.0).&#xD;
&#xD;
                    7. Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy&#xD;
                       with the exception of alopecia, vitiligo, and the laboratory values defined&#xD;
                       in the inclusion criteria.&#xD;
&#xD;
                    8. Venous thromboembolism within 1 month prior to Cycle 1 Day 1.&#xD;
&#xD;
                    9. Current congestive heart failure (New York Heart Association Class II-IV).&#xD;
&#xD;
                   10. History of the following within 6 months prior to Cycle 1 Day 1: a&#xD;
                       myocardial infarction, severe/unstable angina pectoris, coronary/peripheral&#xD;
                       artery bypass graft, New York Heart Association (NYHA) Class III-IV heart&#xD;
                       failure, uncontrolled hypertension, clinically significant cardiac&#xD;
                       dysrhythmia or clinically significant electrocardiogram (ECG) abnormality,&#xD;
                       cerebrovascular accident, transient ischemic attack, or seizure disorder.&#xD;
&#xD;
                   11. Known hepatitis B or C virus (HBV/HCV) infection, known history of human&#xD;
                       immunodeficiency virus (HIV) infection, or receiving immunosuppressive or&#xD;
                       myelosuppressive medications that would in the opinion of the investigator,&#xD;
                       increase the risk of serious neutropenic complications, history of active&#xD;
                       primary immunodeficiency, active tuberculosis (clinical evaluation that&#xD;
                       includes clinical history, physical examination and radiographic findings,&#xD;
                       and TB testing in line with local practice).&#xD;
&#xD;
                   12. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring&#xD;
                       systemic therapy, defined as ongoing signs/symptoms related to the infection&#xD;
                       without improvement despite appropriate antibiotics, antiviral therapy,&#xD;
                       and/or other treatment.&#xD;
&#xD;
                   13. History of interstitial lung disease, history of slowly progressive dyspnea&#xD;
                       and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary&#xD;
                       fibrosis, or pulmonary hypersensitivity pneumonitis or multiple allergies.&#xD;
                       Any lung disease that may interfere with the detection or management of&#xD;
                       suspected drug-related pulmonary toxicity.&#xD;
&#xD;
                   14. Subject has a clinically significant malabsorption syndrome, persistent&#xD;
                       diarrhea, or known sub-acute bowel obstruction &gt; NCI CTCAE Grade 2, despite&#xD;
                       medical management.&#xD;
&#xD;
                   15. Treatment with any chemotherapy, investigational product, biologic or&#xD;
                       hormonal therapy for cancer treatment within 28 days prior to signing the&#xD;
                       ICF. Concurrent use of hormonal therapy for non-cancer-related conditions&#xD;
                       (e.g. hormone replacement therapy) is acceptable.&#xD;
&#xD;
                   16. History of or suspected allergy to any IP or their excipients.&#xD;
&#xD;
                   17. Major surgical procedure (as defined by the Investigator) within 28 days&#xD;
                       prior to the first dose of IP. Note: Local surgery of isolated lesions for&#xD;
                       palliative intent is acceptable.&#xD;
&#xD;
                   18. Currently enrolled in any other clinical protocol or investigational trial&#xD;
                       that involves administration of experimental therapy and/or therapeutic&#xD;
                       devices.&#xD;
&#xD;
                   19. Any other clinically significant medical condition, psychiatric illness,&#xD;
                       and/or organ dysfunction that will interfere with the administration of the&#xD;
                       therapy according to this protocol or which, in the views of investigator,&#xD;
                       preclude combination chemotherapy.&#xD;
&#xD;
                   20. Any other malignancy within 5 years prior to randomization/treatment&#xD;
                       assignement, or advanced malignant hepatic tumors, with the exception of&#xD;
                       adequately treated squamous cell carcinoma of the skin, in-situ carcinoma of&#xD;
                       the cervix, uteri, non-melanomatous skin cancer, carcinoma in situ of the&#xD;
                       breast, or incidental histological finding of prostate cancer (TNM&#xD;
                       Classification of Malignant Tumours (TNM) stage of T1a or T1b). (All&#xD;
                       treatment of which should have been completed 6 months prior to signing&#xD;
                       ICF).&#xD;
&#xD;
                   21. Radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks&#xD;
                       prior to starting IP, and/or from whom ≥ 30% of the bone marrow was&#xD;
                       irradiated. Prior radiation therapy to a target lesion is permitted only if&#xD;
                       there has been clear progression of the lesion since radiation was&#xD;
                       completed.&#xD;
&#xD;
                   22. Any condition including the presence of laboratory abnormalities, which&#xD;
                       places the subject at unacceptable risk if he/she were to participate in the&#xD;
                       study.&#xD;
&#xD;
                   23. Any medical condition that confounds the ability to interpret data from the&#xD;
                       study.&#xD;
&#xD;
                   24. Female patients who are pregnant or breastfeeding or female patients of&#xD;
                       reproductive potential who are not willing to employ effective birth control&#xD;
                       from screening to 90 days after the last dose of durvalumab.&#xD;
&#xD;
                   25. Male patients of reproductive potential who are not willing to employ&#xD;
                       effective birth control from screenin to 90 days after the last dose of&#xD;
                       durvalumab and from screening to 6 months after the last dose of of&#xD;
                       nab-paclitaxel.&#xD;
&#xD;
                   26. History of allogenic organ transplantation.&#xD;
&#xD;
                   27. Current or prior use of immunosuppressive medication within 14 days before&#xD;
                       the first dose of durvalumab. The following are exceptions to this&#xD;
                       criterion:&#xD;
&#xD;
               -  Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra&#xD;
                  articular injection)&#xD;
&#xD;
               -  Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of&#xD;
                  prednisone or its equivalent&#xD;
&#xD;
               -  Steroids as premedication for hypersensitivity reactions (eg, CT scan&#xD;
                  premedication) 28. Receipt of live attenuated vaccine within 30 days prior to the&#xD;
                  first dose of IP. Note: Patients, if enrolled, should not receive live vaccine&#xD;
                  during the study and up to 30 days after the last dose of IP.&#xD;
&#xD;
                  29. Prior enrollment and treatment in a previous durvalumab clinical study. 30.&#xD;
                  Patients who have received prior anti-PD-1 or anti PD-L1:&#xD;
&#xD;
               -  Must not have experienced a toxicity that led to permanent discontinuation of&#xD;
                  prior immunotherapy.&#xD;
&#xD;
               -  All AEs while receiving prior immunotherapy must have completely resolved or&#xD;
                  resolved to baseline prior to screening for this study.&#xD;
&#xD;
               -  Must not have experienced a ≥ Grade 3 immune related AE or an immune related&#xD;
                  neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE:&#xD;
                  Subjects with endocrine AE of ≤ Grade 2 are permitted to enroll if they are&#xD;
                  stably maintained on appropriate replacement therapy and are asymptomatic.&#xD;
&#xD;
               -  Must not have required the use of additional immunosuppression other than&#xD;
                  corticosteroids for the management of an AE, not have experienced recurrence of&#xD;
                  an AE if re-challenged, and not currently require maintenance doses of &gt; 10 mg&#xD;
                  prednisone or equivalent per day.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSF Helen Diller Medical Center at Parnassus Heights</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Central Connecticut Gynecologic Oncology</name>
      <address>
        <city>New Britain</city>
        <state>Connecticut</state>
        <zip>06050</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Cancer and Blood Center, LLC</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 603</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
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  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>July 13, 2018</results_first_submitted>
  <results_first_submitted_qc>August 9, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">August 10, 2018</results_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
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  <keyword>Cancer of the lung</keyword>
  <keyword>lung neoplasm</keyword>
  <keyword>NSCLC - non-small cell lung cancer</keyword>
  <keyword>Nonsquamou</keyword>
  <keyword>squamous</keyword>
  <keyword>squamous NSCLC</keyword>
  <keyword>Tumor</keyword>
  <keyword>locally advanced NSCLC</keyword>
  <keyword>metastatic NSCLC</keyword>
  <keyword>advanced lung cancer</keyword>
  <keyword>metastatic lung cancer</keyword>
  <keyword>non-squamous NSCLC</keyword>
  <keyword>lung cancer</keyword>
  <keyword>Abraxane</keyword>
  <keyword>ABI-007</keyword>
  <keyword>nab-paclitaxel</keyword>
  <keyword>albumin-bound paclitaxel</keyword>
  <keyword>taxanes</keyword>
  <keyword>CC-486</keyword>
  <keyword>oral azacitidine</keyword>
  <keyword>azacitidine</keyword>
  <keyword>second line treatment of lung cancer</keyword>
  <keyword>second line treatment</keyword>
  <keyword>Celgene</keyword>
  <keyword>abound.2L</keyword>
  <keyword>third line treatment</keyword>
  <keyword>durvalumab</keyword>
  <keyword>immunotherapy</keyword>
  <keyword>MEDI4736</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Azacitidine</mesh_term>
    <mesh_term>Cc-486</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: ABI_007-NSCL_Protocol_AM5_Redacted_09December 2016</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>December 9, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02250326/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: ABI-007-NSCL-006_Protocol_AM4_Redacted.31May2016</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>May 31, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02250326/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: ABI_007-NSCL_Protocol_AM3_Redacted_14 April 2016</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>April 14, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02250326/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: ABI_007-NSCL_Protocol_AM2_Redacted_18July2014</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 18, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02250326/Prot_004.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: ABI_007-NSCL_Protocol_AM1_Redacted_24 June 2014</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>June 24, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02250326/Prot_005.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: ABI_007-NSCL_Protocol_Original_Redacted_29May2014</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>May 29, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02250326/Prot_006.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 25, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/26/NCT02250326/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a multicenter study with 34 sites from the United States, Canada, France, Germany, Italy, Spain and the United Kingdom.</recruitment_details>
      <pre_assignment_details>Eligible participants included those with advanced non-small cell lung cancer who had received no more than one prior containing chemotherapy regimen. Immunotherapy as a prior line of treatment was allowed. Randomization was stratified by eastern cooperative oncology group performance status, gender and the smoking status of the participant.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
        </group>
        <group group_id="P2">
          <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
        </group>
        <group group_id="P3">
          <title>Nab-Paclitaxel Monotherapy Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="79"/>
                <participants group_id="P3" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated Population</title>
              <participants_list>
                <participants group_id="P1" count="79"/>
                <participants group_id="P2" count="78"/>
                <participants group_id="P3" count="79"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">Data Cut-off Date = 30 August 2017</participants>
                <participants group_id="P2" count="15">Data Cut-off Date = 23 December 2017</participants>
                <participants group_id="P3" count="3">Data Cut-off Date = 30 August 2017</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="81"/>
                <participants group_id="P2" count="64"/>
                <participants group_id="P3" count="77"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="36"/>
                <participants group_id="P3" count="45"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Symptomatic Deterioration</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized or assigned; not treated</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Follow-Up Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="43"/>
                <participants group_id="P3" count="64"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="38"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="26"/>
                <participants group_id="P3" count="32"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unknown or Missing</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent to Treat (ITT) Population included all assigned participants regardless of whether the participant received any investigational product (IP) or had any efficacy assessments performed.</population>
      <group_list>
        <group group_id="B1">
          <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
        </group>
        <group group_id="B2">
          <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
        </group>
        <group group_id="B3">
          <title>Nab-Paclitaxel Monotherapy Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
        </group>
        <group group_id="B4">
          <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="81"/>
            <count group_id="B2" value="79"/>
            <count group_id="B3" value="80"/>
            <count group_id="B4" value="240"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.0" spread="9.00"/>
                    <measurement group_id="B2" value="62.7" spread="10.74"/>
                    <measurement group_id="B3" value="62.6" spread="9.58"/>
                    <measurement group_id="B4" value="63.1" spread="9.77"/>
                  </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="31"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="50"/>
                    <measurement group_id="B4" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="207"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>ECOG performance status is used by doctors and researchers to assess how a subject's disease is progressing, assess how the disease affects the daily living activities of the subject and determine appropriate treatment and prognosis. 0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 = Fully Active</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 = Restrictive but ambulatory</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="171"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 = Ambulatory but unable to work</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Current Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Past Smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="63"/>
                    <measurement group_id="B4" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Never Smoked</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Confirmed Histology</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Adenocarcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Large Cell Carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adenosquamous Carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carcinoid Tumor</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Squamous Cell</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease Stage at Enrollment</title>
          <description>Disease stage means how big the tumor is and how far it has spread. Disease stages range from 0 (no spread) to IV (spread throughout the body). Stage 1 - the cancer is small and hasn't spread to the lymph nodes; Stage II - the cancer has spread to some lymph nodes near the tumor; Stage IIIA the cancer has spread to lymph nodes on the same side of the tumor; Stage IIIB - the the cancer has spread to the lymph nodes above the collarbone or in the opposite side of the chest tumor; Stage IV - the cancer has spread to other organs such as the other lung, brain or liver.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Stage IIIa</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage IIIb</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stage IV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator</title>
        <description>Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.</description>
        <time_frame>From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months</time_frame>
        <population>Intent to Treat Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Nab-Paclitaxel Alone</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator</title>
          <description>Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.</description>
          <population>Intent to Treat Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="2.30" upper_limit="4.30"/>
                    <measurement group_id="O2" value="4.5" lower_limit="3.45" upper_limit="5.88"/>
                    <measurement group_id="O3" value="4.2" lower_limit="2.79" upper_limit="5.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Based on stratified Cox proportional hazards regression model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.94</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria</title>
        <description>Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows:&#xD;
Complete Response is the disappearance of all target lesions;&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline;&#xD;
Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks.</description>
        <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
        <population>ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Nab-Paclitaxel Alone</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria</title>
          <description>Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows:&#xD;
Complete Response is the disappearance of all target lesions;&#xD;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline;&#xD;
Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks.</description>
          <population>ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.</population>
          <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="81"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.4" lower_limit="54.0" upper_limit="75.7"/>
                    <measurement group_id="O2" value="70.9" lower_limit="59.6" upper_limit="80.6"/>
                    <measurement group_id="O3" value="67.5" lower_limit="56.1" upper_limit="77.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Disease Control Rate Ratio</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.778</ci_lower_limit>
            <ci_upper_limit>1.207</ci_upper_limit>
            <estimate_desc>95% CI was calculated using Clopper-Pearson method.</estimate_desc>
            <other_analysis_desc>Direction of Disease Control Rate Ratio is DCR of Nab-Paclitaxel + CC-486 Combination Arm over DCR of Nab-Paclitaxel Alone</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria</title>
        <description>Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.</description>
        <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
        <population>ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Nab-Paclitaxel Alone</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria</title>
          <description>Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.</description>
          <population>ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.</population>
          <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="81"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" lower_limit="7.0" upper_limit="23.0"/>
                    <measurement group_id="O2" value="27.8" lower_limit="18.3" upper_limit="39.1"/>
                    <measurement group_id="O3" value="16.3" lower_limit="8.9" upper_limit="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Overall Response Rate Ratio</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.398</ci_lower_limit>
            <ci_upper_limit>1.754</ci_upper_limit>
            <estimate_desc>95% CI was calculated using Clopper-Pearson method.</estimate_desc>
            <other_analysis_desc>Direction of Overall Response Rate Ratio is ORR of Nab-Paclitaxel + CC-486 Combination Arm over ORR of nab-Paclitaxel Alone.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kaplan Meier Estimate of Overall Survival (OS)</title>
        <description>Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.</description>
        <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months</time_frame>
        <population>ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Nab-Paclitaxel Alone</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Kaplan Meier Estimate of Overall Survival (OS)</title>
          <description>Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.</description>
          <population>ITT Population included all randomized or assigned participants regardless of whether the participant received any study drug or had any efficacy assessments performed.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" lower_limit="6.64" upper_limit="11.86"/>
                    <measurement group_id="O2" value="10.1" lower_limit="7.75" upper_limit="NA">The 95% CI upper bound of the median OS time is not estimable, because the survival rate is greater than 40% for all values of time, therefore, no time that corresponding to the 40% survival rate and below.</measurement>
                    <measurement group_id="O3" value="17.0" lower_limit="8.21" upper_limit="NA">The 95% CI upper bound of the median OS time is not estimable, because the survival rate is greater than 40% for all values of time, therefore, no time that corresponding to the 40% survival rate and below.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Based on stratified Cox proportional hazards regression model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.08</ci_lower_limit>
            <ci_upper_limit>2.57</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period</title>
        <description>TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.</description>
        <time_frame>TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 86.1 weeks</time_frame>
        <population>Safety Population included all participants who were randomized or assigned and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Nab-Paclitaxel Alone</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period</title>
          <description>TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.</description>
          <population>Safety Population included all participants who were randomized or assigned and received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="78"/>
                    <measurement group_id="O3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="37"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade (GR) 3/4 TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 or Higher</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Related TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Related Serious TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Related GR 3 or Higher TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE With Action to Reduce/Interrupt IP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="57"/>
                    <measurement group_id="O3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Related to Reduce or Interrupt IP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE with Action Taken to Withdraw IP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAE with Fatal Outcome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment Related TEAE with Fatal Outcome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Discontinued Study Treatment</title>
        <description>The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.</description>
        <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
        <population>Treated population included all participants who were randomized or assigned and received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Nab-Paclitaxel Alone</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Discontinued Study Treatment</title>
          <description>The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.</description>
          <population>Treated population included all participants who were randomized or assigned and received at least 1 dose of study drug.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="79"/>
                <count group_id="O3" value="80"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="80.8"/>
                    <measurement group_id="O3" value="96.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Intensity Per Week of Nab-Paclitaxel</title>
        <description>Dose intensity was the cumulative dose divided by the dosing period in weeks.</description>
        <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
        <population>The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Nab-Paclitaxel Alone</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Intensity Per Week of Nab-Paclitaxel</title>
          <description>Dose intensity was the cumulative dose divided by the dosing period in weeks.</description>
          <population>The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of IP.</population>
          <units>mg/m^2/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.73" spread="11.390"/>
                    <measurement group_id="O2" value="57.18" spread="13.605"/>
                    <measurement group_id="O3" value="58.61" spread="14.893"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Intensity Per Week of CC-486</title>
        <description>Dose intensity was the cumulative dose divided by the dosing period in weeks.</description>
        <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
        <population>The treated population consisted of all participants who randomized or assigned and received at least 1 dose of IP.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Intensity Per Week of CC-486</title>
          <description>Dose intensity was the cumulative dose divided by the dosing period in weeks.</description>
          <population>The treated population consisted of all participants who randomized or assigned and received at least 1 dose of IP.</population>
          <units>mg/ week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="716.66" spread="220.945"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Intensity Per Week of Durvalumab</title>
        <description>Dose intensity was the cumulative dose divided by the dosing period in weeks).</description>
        <time_frame>Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
        <population>The treated population consisted of all participants who randomized or assigned and received at least 1 dose of investigational Product.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Intensity Per Week of Durvalumab</title>
          <description>Dose intensity was the cumulative dose divided by the dosing period in weeks).</description>
          <population>The treated population consisted of all participants who randomized or assigned and received at least 1 dose of investigational Product.</population>
          <units>mg/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="279.96" spread="97.304"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Study Drug Dose Reductions</title>
        <description>A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.</description>
        <time_frame>Up to 16 Jan 2017 for CC-486 + nab-paclitaxel and up to 23 Dec 2017 for nab-paclitaxel and Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel</time_frame>
        <population>The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of investigational product.</population>
        <group_list>
          <group group_id="O1">
            <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
          <group group_id="O3">
            <title>Nab-Paclitaxel Alone</title>
            <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Study Drug Dose Reductions</title>
          <description>A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.</description>
          <population>The treated population consisted of all participants who were randomized or assigned and received at least 1 dose of investigational product.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="79"/>
                <count group_id="O2" value="78"/>
                <count group_id="O3" value="79"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Nab-Paclitaxel</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                    <measurement group_id="O2" value="14.1"/>
                    <measurement group_id="O3" value="10.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CC-486</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Durvalumab (Reductions Not Allowed per Protocol)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="78"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 86.1 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nab-Paclitaxel + CC-486 Combination Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg tablets on Days 1 to 14 of each 21-day treatment cycle until disease progression (DP), development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
        </group>
        <group group_id="E2">
          <title>Nab-Paclitaxel + Durvalumab Combination Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by IV infusion over 30 minutes on Days 1and 8 and durvalumab (durva) 1125 mg/m^2 by IV infusion over 1 hour on Day 15 of each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</description>
        </group>
        <group group_id="E3">
          <title>Nab-Paclitaxel Monotherapy Arm</title>
          <description>Participants received nab-paclitaxel 100 mg/m^2 by intravenous infusion over 30 minutes on Days 1 and 8 each 21-day treatment cycle until disease progression, development of an unacceptable toxicity, death, lost to follow-up, or withdrawal of consent, in accordance with local standard of care.</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="53" subjects_at_risk="81"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="79"/>
                <counts group_id="E3" subjects_affected="37" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="79"/>
              </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="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Duodenal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Performance status decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Postoperative fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Procedural pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>White blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Metabolic alkalosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Balance disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Generalised tonic-clonic seizure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Paraparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </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="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory distress syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </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="78" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="78" subjects_at_risk="79"/>
              </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="12" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="79"/>
              </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="27" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="24" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
              </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="25" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="79"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="79"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="79"/>
              </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>Results from a center cannot be submitted for publication before results of multicenter study are published unless it is more than one year since study completion.Then, Investigator can publish if manuscript is submitted to Celgene 60 days prior to submission. If Celgene decides publication would hinder drug development, Investigator must delay submission for up to ninety days. Investigator must delete confidential information before submission or defer publication to permit patent applications.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anne McClain, Senior Manager, Clinical Trial Disclosure</name_or_title>
      <organization>Celgene Corporation</organization>
      <phone>1-888-260-1599</phone>
      <email>ClinicalTrialDisclosure@Celgene.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/NCT02250326
org study id: ABI-007-NSCL-006
secondary id: 2014-001105-41
nct id: NCT02250326
lead sponsor: 
has dmc: Yes
This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of
      second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying
      therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects
      with advanced non-small cell lung cancer (NSCLC).
This Phase 2 study will test the hypothesis that epigenetic modifying therapy of CC-486 or
      immunotherapy of durvalumab can improve the anti-tumor activity of nab-paclitaxel in subjects
      with advanced non-small cell lung cancer (NSCLC) who have received no more than one prior
      chemotherapy regimen for their advanced disease. It will further assess efficacy and safety
      of nab-paclitaxel monotherapy in this setting. Each subject will receive study therapy as
      second- or third-line of treatment. Approximately 240 male and female subjects with advanced
      NSCLC will be assigned to one of the following treatment arms (approximately 80 subjects per
      group): nab-paclitaxel /CC-486 combination therapy, nab-paclitaxel/durvalumab combination
      therapy or nab-paclitaxel monotherapy prior to receiving first dose of Investigational
      Product. A permuted-block randomization method will be employed to assign the subjects among
      the treatment arms that are enrolling simultaneously, when applicable, stratified by the
      following baseline factors: ECOG performance status (0 versus 1), gender (males versus
      females), and smoker (yes versus no). Treatment assignments of subjects to the
      nab-paclitaxel/CC-486 combination therapy and nab-paclitaxel monotherapy arms will be
      conducted completely in a randomized fashion.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Kaplan Meier Estimate of Progression-Free Survival (PFS) as Assessed by the Investigator
time frame: From date of first dose of IP to DP; up to data cut-off date of 30 August (Aug) 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 December (Dec) 2017 for Durva + nab-paclitaxel; participants were followed for PFS for up to 18 months
description: Progression-free survival was defined as the time in months from the date of randomization/assignment to the date of disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria documented by computed tomography (CT) scan, not including symptomatic deterioration, or death (any cause) on or prior to the clinical cut-off date, which ever occurred earlier. Participants who did not have disease progression and had not died, regardless of whether they were discontinued from treatment, were censored at the date of last tumor assessment, on or prior to the clinical cut-off date that the participant was progression free. Progressive Disease was defined as at least a 20% increase in the sum of diameters of target lesions from nadir.
measure: Percentage of Participants Who Achieved a Complete Response (CR), Partial Response (PR) or Stable Disease (SD) According to RECIST V 1.1 Criteria
time frame: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
description: Disease control rate was defined as the percentage of participants who had a CR, PR or SD during the course of the study, according to RECIST version 1.1 criteria, as evaluated by the investigator. RECIST Version 1.1 criteria is defined as follows:
Complete Response is the disappearance of all target lesions;
Partial Response is at least a 30% decrease in the sum of diameters of target lesions from baseline;
Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase of lesions to qualify for progressive disease. Responses were evaluated every 6 weeks.
measure: Percentage of Participants Who Achieved a Best Overall Response of Complete Response or Partial Response According to RECIST V 1.1 Criteria
time frame: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
description: Overall Response was defined as percentage of participants who achieved a radiologic confirmed complete response or partial response according to RECIST V 1.1 criteria and compared with baseline among all tumor assessments, where baseline was the last CT obtained prior to or on Day 1 of treatment. Per RECIST V 1.1 criteria, a CR is defined as a disappearance of all target lesions; a PR is defined as having at least a 30% decrease in the sum of diameters of target lesions from baseline. Responses were evaluated every 6 weeks.
measure: Kaplan Meier Estimate of Overall Survival (OS)
time frame: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; participants were followed for overall survival up to 30 months
description: Overall survival was defined as the time in months between randomization/treatment assignment and death from any cause. Participants who were still alive as of the clinical cut-off date had their OS censored at the date of last contact or clinical cut-off, whichever was earlier. Participants who were lost to follow-up prior to the end of the study or who were withdrawn from the study were censored at the time of last contact.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Entire Treatment Period
time frame: TEAEs were collected up to 4 weeks after receiving last dose of IP for nab-paclitaxel and CC-486 + nab-paclitaxel, and up to 90 days after the last IP dose for Durva + nab-paclitaxel; TEAEs were collected up to 86.1 weeks
description: TEAEs were defined as any adverse event or serious adverse event that occurred or worsened on or after the day of the first dose of the IP through 28 days after the last dose of IP for Arms A and C or up to 90 days after the last dose for Arm B, and those SAEs made known to the investigator at any time thereafter that are suspected of being related to IP. A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs were graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild l intervention/therapy required Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death.
measure: Percentage of Participants Who Discontinued Study Treatment
time frame: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
description: The discontinuation rate was defined as the percentage of participants who had study drug discontinued and was assessed throughout the conduct of the study.
measure: Dose Intensity Per Week of Nab-Paclitaxel
time frame: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
description: Dose intensity was the cumulative dose divided by the dosing period in weeks.
measure: Dose Intensity Per Week of CC-486
time frame: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
description: Dose intensity was the cumulative dose divided by the dosing period in weeks.
measure: Dose Intensity Per Week of Durvalumab
time frame: Up to 30 Aug 2017 for nab-paclitaxel and CC-486 + nab-paclitaxel and 23 Dec 2017 for Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
description: Dose intensity was the cumulative dose divided by the dosing period in weeks).
measure: Percentage of Participants With Study Drug Dose Reductions
time frame: Up to 16 Jan 2017 for CC-486 + nab-paclitaxel and up to 23 Dec 2017 for nab-paclitaxel and Durva + nab-paclitaxel; maximum treatment duration = 82.1 weeks, 52.6 weeks and 66.1 weeks for nab-paclitaxel, CC-486 + nab-paclitaxel and Durva + nab-paclitaxel
description: A dose reduction occurred when the dose assigned at a visit was lower than the dose assigned at the previous visit. Dose reductions were typically caused by clinically significant laboratory abnormalities and/or TEAEs or toxicities.
arm group label: Combination arm: nab-paclitaxel and CC-486
arm group type: Experimental
description: Subjects in the combination arm will receive nab-paclitaxel 100 mg^/m2 intravenous (IV) infusion over 30 minutes on Days 8 and 15 and CC-486 200 mg orally daily (QD) on Days 1 to14 of each 21-day treatment cycle
arm group label: Monotherapy arm: nab-paclitaxel IV infusion
arm group type: Experimental
description: Subjects in the monotherapy arm will receive nab-Paclitaxel 100 mg/m^2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day treatment cycle
arm group label: Nab-paclitaxel and Durvalumab combination
arm group type: Experimental
description: subjects in the nab-Paclitaxel/durvalumab combination arm will receive nab-Paclitaxel 100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and durvalumab 1125 mg IV infusion over approximately 1 hour on Day 15 of each 21-day treatment cycle
intervention type: Drug
intervention name: nab-paclitaxel IV
description: nab-Paclitaxel intravenous (IV) infusion
arm group label: Combination arm: nab-paclitaxel and CC-486
arm group label: Monotherapy arm: nab-paclitaxel IV infusion
arm group label: Nab-paclitaxel and Durvalumab combination
other name: Abraxane
other name: ABI-007
intervention type: Drug
intervention name: CC-486
description: Oral CC-486
arm group label: Combination arm: nab-paclitaxel and CC-486
other name: Oral AZA
other name: Oral azacitidine
intervention type: Drug
intervention name: Duravalumab
arm group label: Nab-paclitaxel and Durvalumab combination
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Canada
country: France
country: Germany
country: Italy
country: Spain
country: United Kingdom
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.BMSStudyConnect.com
description: BMS Clinical Trial Patient Recruiting
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responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Azacitidine
mesh term: Cc-486
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