<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/NCT01730118</url>
  </required_header>
  <id_info>
    <org_study_id>130016</org_study_id>
    <secondary_id>13-C-0016</secondary_id>
    <nct_id>NCT01730118</nct_id>
  </id_info>
  <brief_title>Ad/HER2/Neu Dendritic Cell Cancer Vaccine Testing</brief_title>
  <official_title>A Phase I Study of an Adenoviral Transduced Autologous Dendritic Cell Vaccine Expressing Human HER2/Neu ECTM in Adults With Tumors With 1-3+ HER2/Neu Expression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      - Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu)/neu (HER2) is&#xD;
      a tumor protein that appears in almost a third of breast cancers and in several other types&#xD;
      of cancers such as colon, prostate and non-small cell lung. Tumors that overexpress HER2 can&#xD;
      be associated with a more aggressive cancer, higher recurrence rates, and reduced survival&#xD;
      rates. Researchers are testing a therapeutic cancer vaccine designed to stimulate the immune&#xD;
      system to recognize HER2. The vaccine, called adenoviral transduced autologous human&#xD;
      epidermal growth factor receptor (AdHER)/neu dendritic cell vaccine, is custom-made using an&#xD;
      individual's own immune cells. These cells will be collected and used to produce the vaccine.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To test the safety and effectiveness of AdHER2 vaccination.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Individuals at least 18 years of age who have HER2-expressing tumors.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be screened with a physical exam and medical history. Blood and urine&#xD;
           samples will be collected. Imaging studies will also be performed.&#xD;
&#xD;
        -  Participants will have an apheresis procedure to collect immune cells to create the&#xD;
           vaccine.&#xD;
&#xD;
        -  Participants will receive five doses of the vaccine at study Weeks 0, 4, 8, 16 and 24.&#xD;
&#xD;
        -  Participants will be monitored with physical exams, frequent blood tests and imaging&#xD;
           studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
        -  Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu) is a&#xD;
           proto-oncogene that encodes a 185-kd transmembrane tyrosine kinase receptor that&#xD;
           participates in receptor-receptor interactions that regulate cell growth,&#xD;
           differentiation and proliferation. Its over-expression contributes to neoplastic&#xD;
           transformation.&#xD;
&#xD;
        -  HER2 is over-expressed in up to 25-30% of node-positive or node-negative primary breast&#xD;
           cancers and is associated with clinically aggressive breast cancer, a high recurrence&#xD;
           rate and reduced survival.&#xD;
&#xD;
        -  Trastuzumab (Herceptin (Registered trademark)) is a recombinant humanized mouse&#xD;
           monoclonal antibody (MAb) that binds to the extracellular (EC) domain of the HER2&#xD;
           receptor. Its clinical efficacy is limited to patients with 3+ HER2 tumor expression&#xD;
           documented by immunohistochemistry (IHC) or a Vysis fluorescent in situ hybridization&#xD;
           (FISH) ratio of greater than 2.2. IHC is a subjective measurement of HER2/neu protein&#xD;
           while FISH is an objective measurement of amplification of the HER2 oncogene.&#xD;
&#xD;
        -  Although the use of trastuzumab has been associated with improved clinical outcomes, a&#xD;
           significant number of patients are unresponsive to therapy and most eventually&#xD;
           experience clinical progression. At present no vaccine is available that induces&#xD;
           patients to make their own anti-HER2 antibodies.&#xD;
&#xD;
        -  We propose to investigate the use of an adenoviral vector (Ad5f35) expressing human&#xD;
           HER2ECTM (Ad5f35HER2ECTM- AdHER2) to transduce autologous dendritic cells for&#xD;
           therapeutic vaccination in patients with HER2 expressing solid tumors.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      -To determine the safety and toxicity of autologous AdHER2 dendritic cell vaccination.&#xD;
&#xD;
      Specifically, to determine if the fraction of patients with cancer therapeutics-related&#xD;
      cardiac dysfunction (CTRCD), defined as a decrease in left ventricular ejection fraction&#xD;
      (LVEF) &gt;=10 percentage points, to a value LVEF to less than or equal to 53% (normal reference&#xD;
      value for two-dimensional (2-D) echocardiography), is sufficiently low to warrant further&#xD;
      development in subsequent trials.&#xD;
&#xD;
      -To determine the immunogenicity of autologous AdHER2 dendritic cell vaccination as measured&#xD;
      by a 3-fold increase in anti-HER2/neu antibody concentration or a 4-fold increase in antibody&#xD;
      dilution titers over baseline.&#xD;
&#xD;
      Study Design:&#xD;
&#xD;
      Open label, non-randomized, two-part, phase I study of 48 weeks duration for evaluation of&#xD;
      primary endpoints with extended follow-up out to 30 months to monitor LVEF cardiac function.&#xD;
&#xD;
      Part I involves vaccine dose escalation in a population with no prior exposure to trastuzumab&#xD;
      or other HER2-targeted therapies to determine if there is a significant, adverse safety&#xD;
      signal regarding cardiac toxicity, in addition to preliminary assessment of the vaccine s&#xD;
      immunogenicity and clinical activity. Five doses of 5, 10, 20 or 40 x 10(6) viable&#xD;
      cells/AdHER2 DC vaccine will be given intradermally at Weeks 0, 4, 8, 16 and 24 in patients&#xD;
      with metastatic solid tumors or high risk bladder cancer in the adjuvant setting Response&#xD;
      will be evaluated by a Modified Immune- Related Response Criteria (irRC) based on Response&#xD;
      Evaluation Criteria in Solid Tumors&#xD;
&#xD;
      (Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (modified irRC) at Weeks 8, 16,&#xD;
      24, 36 and 48 with confirmatory scans obtained not less than 4 weeks following initial&#xD;
      documentation of objective response. Adjuvant bladder cancer patients will undergo re-staging&#xD;
      at Weeks 8, 16, 24, 36 and 48 with confirmatory scans obtained not less than 4 weeks&#xD;
      following initial documentation of objective response.&#xD;
&#xD;
      Part II is identical to part I, in the schedule of treatment and response evaluation, but is&#xD;
      conducted in a population with prior exposure to trastuzumab and other HER2-targeted&#xD;
      therapies.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      Part I:&#xD;
&#xD;
        -  Adults &gt;= 18 with recurrent, metastatic solid tumors for whom trastuzumab is not&#xD;
           clinically indicated in standard of care OR who are naive to HER2 targeted therapies:&#xD;
&#xD;
        -  Patients with ovarian, cervical, colon, non-small cell lung, renal cell, bladder and&#xD;
           prostate cancer, and malignant soft tissue and bone tumor or other solid tumors that is&#xD;
           HER2 1+, 2+ or 3+ by IHC OR have a Vysis FISH result greater than or equal to 1.8.&#xD;
&#xD;
             -  Patients with breast cancer that is HER2 1+ or 2+ by IHC or with a Vysis FISH&#xD;
                result less than or equal to 1.8 - less than or equal to 2.2.&#xD;
&#xD;
             -  Measurable disease, with the exception of metastatic bladder cancer patients that&#xD;
                have completed first line chemotherapy and may not have measurable disease.&#xD;
&#xD;
        -  Adults greater than or equal to 18 with HER2+ bladder cancer in the adjuvant setting&#xD;
&#xD;
             -  Tumor stage T3a, T3b, T4a and T4b or any node positive disease.&#xD;
&#xD;
             -  Tumors that are HER2 1+, 2+ or 3+ by IHC or have a Vysis FISH result greater than&#xD;
                or equal to 1.8.&#xD;
&#xD;
             -  greater than or equal to 6 weeks status post primary surgery with curative intent.&#xD;
&#xD;
             -  Eastern Cooperative Oncology Group (ECOG) 0-1.&#xD;
&#xD;
             -  Naive to trastuzumab, pertuzumab, lapatinib, ado-trastuzumab emtansine (TDM1) or&#xD;
                other HER2-directed therapies.&#xD;
&#xD;
      Part II:&#xD;
&#xD;
        -  Adults &gt;= 18 with breast, gastric or gastroesophageal junction or other cancers with 1+&#xD;
           to 3+ HER2/neu expression by IHC or a Vysis FISH result &gt; 2.2.&#xD;
&#xD;
        -  Recurrent metastatic disease, ECOG 0-1. Disease progression following HER2-targeted&#xD;
           therapies. i.e., trastuzumab, pertuzumab, lapatinib, ado-trastuzumab emtansine or other&#xD;
           HER2 agents.&#xD;
&#xD;
        -  Measurable disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2013</start_date>
  <completion_date type="Actual">December 3, 2019</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Cardiac Toxicity</measure>
    <time_frame>Baseline through receipt of last dose of vaccine, up to 24 weeks</time_frame>
    <description>Cardiac toxicity defined as cardiac dysfunction due to damage to the heart muscles or valves. Cardiac toxicity was assessed by serial echocardiography to determine left ventricular ejection fraction (LVEF) at baseline and following receipt of the last dose of vaccine. Cardiac toxicity is at least a 10% decline from the baseline in cardiac function. Normal LVEF is &gt;-53%. Below 53% is a cardiac dysfunction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Develop at Least a 4-fold or 2.5- Fold Increase in Anti-Human Epidermal Growth Factor Receptor (HER2)/Neu Antibody Dilution Titers</measure>
    <time_frame>Baseline through last dose of vaccine, up to 24 weeks</time_frame>
    <description>Vaccine immunogenicity was determined by the number of participants who develop at least a 4-fold increase in antibody dilution titers over baseline at the time points measured. The antibody response following the vaccination was assessed using peptide-array and reported as fold increase compared to the baseline values using the cut-off of 4 fold per study definition of the vaccine immunogenicity and also of 2.5 fold to aid the interpretation of the result.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)</measure>
    <time_frame>At 8, 16, 24, 36, 48, 76, 100, and 124 weeks after initial vaccination</time_frame>
    <description>Number of participants who experienced tumor shrinkage or stabilization that is sufficient by modified immune response related criteria (irRC) to be considered stable disease (SD), a partial response (PR) or better (complete response (CR). SD is neither partial response nor progressive disease (PD). PR is ≥ 30% decrease in tumor burden compared with baseline, confirmation required. CR is disappearance of all target and non-target lesions. Lymph nodes must regress to &lt;10mm short axis. No new lesions, confirmation required. PD ≥ 20% increase in tumor burden compared with baseline, with nadir, or reset baseline. New lesions added to the tumor burden, confirmation required.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)</measure>
    <time_frame>Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.</time_frame>
    <description>Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</description>
  </other_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Breast Neoplasms</condition>
  <condition>Breast Cancer</condition>
  <condition>Adenocarcinomas</condition>
  <condition>Metastatic Solid Tumors Characterized by HER2/Neu Expression</condition>
  <arm_group>
    <arm_group_label>1/Part I dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at escalating doses</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2/Part I dose expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at a next lower dose or the highest dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3/Part 1 dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at Dose Level 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4/Part II dose escalation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at Dose Level 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5/Part II dose expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at Arm 1 maximum tolerated dose (MTD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adenoviral Transduced Autologous Human Epidermal Growth Factor Receptor (AdHER)2/neu Dendritic Cell (DC) Vaccine</intervention_name>
    <description>autologous AdHER2 transduced dendritic cell vaccine manufactured under Good Manufacturing Practices (GMP) conditions from cryopreserved patient monocytes here at the National Institutes of Health (NIH) Clinical Center (CC) Department of Transfusion Medicine (DTM). Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16 and 24 of the study.</description>
    <arm_group_label>1/Part I dose escalation</arm_group_label>
    <arm_group_label>2/Part I dose expansion</arm_group_label>
    <arm_group_label>3/Part 1 dose escalation</arm_group_label>
    <arm_group_label>4/Part II dose escalation</arm_group_label>
    <arm_group_label>5/Part II dose expansion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  ELIGIBILITY CRITERIA:&#xD;
&#xD;
        Common Eligibility for Parts I and II&#xD;
&#xD;
          -  Adults greater than or equal to 18 with malignant soft tissue and bone tumors and&#xD;
             recurrent or progressive, metastatic solid tumors who have progressed on standard&#xD;
             therapies except in adjuvant for high risk bladder cancer in Part I.&#xD;
&#xD;
          -  Recurrent or progressive disease on prior standard therapies with known clinical&#xD;
             benefit with the exception of adjuvant bladder cancer population.&#xD;
&#xD;
          -  Performance Status: Eastern Cooperative Oncology Group (ECOG) 0-1.&#xD;
&#xD;
          -  Baseline left ventricular ejection fraction (LVEF) by two-dimensional (2D)&#xD;
             Echocardiogram greater than or equal to 53%.&#xD;
&#xD;
          -  Greater than or equal to 1 week since standard or investigational treatment for&#xD;
             metastatic disease.&#xD;
&#xD;
          -  Stable, concurrent use of hormone therapy for hormone receptor positive breast cancer&#xD;
             is permitted.&#xD;
&#xD;
          -  Hematologic parameters: absolute neutrophil count (ANC) greater than or equal to 1000&#xD;
             cells/mm^3, absolute lymphocyte count (ALC) greater than or equal to 300 cells/mm^3,&#xD;
             Hemoglobin greater than or equal to 9.0 gm/dL, white blood cell (WBC) greater than or&#xD;
             equal to 2,500 cells/mm^3, platelet count greater than or equal to 75,000/mm^3,&#xD;
             prothrombin time (PT)/partial thromboplastin time (PTT) less than or equal to 1.5X the&#xD;
             upper limits of normal.&#xD;
&#xD;
          -  Chemistry parameters: Creatinine less than or equal to 1.5 mg/dL, serum&#xD;
             glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase&#xD;
             (SGPT) less than or equal to 3X the upper limits of normal and total bilirubin less&#xD;
             than or equal to 1.5 mg/dl, Alkaline phosphatase (Alk PO4) less than or equal to 3X&#xD;
             the upper limits of normal (except for patients with documented metastatic disease to&#xD;
             bone and/or liver).&#xD;
&#xD;
          -  Negative serum beta human chorionic gonadotropin (HCG) if female and of childbearing&#xD;
             potential.&#xD;
&#xD;
          -  Negative human immunodeficiency virus (HIV) 1/2 serology and sample drawn for human&#xD;
             T-cell lymphotropic virus (HTLV). Patients with HIV are excluded from participating on&#xD;
             this clinical trial because their immunodeficiency would confound the evaluation of&#xD;
             adverse events which would hinder meeting the primary objective.&#xD;
&#xD;
          -  Negative serology for hepatitis B and C unless the result is consistent with prior&#xD;
             vaccination or prior infection with full recovery.&#xD;
&#xD;
          -  Willingness of female and male subjects to use effective contraception e.g., oral&#xD;
             contraceptives, barrier device, intrauterine device, or condoms, during the study and&#xD;
             for three months following the last dose of study vaccine. We suggest that subjects do&#xD;
             not become pregnant or father a child during the study, and for 3 months following&#xD;
             receipt of the investigational adenoviral transduced autologous human epidermal growth&#xD;
             factor receptor (AdHER) dendritic cell (DC) vaccine.&#xD;
&#xD;
          -  Able to understand and provide Informed Consent.&#xD;
&#xD;
          -  Patients with 1+ to 3+ human epidermal growth factor receptor 2 (HER2)/neu expression&#xD;
             by immunohistochemistry (IHC) or an equivocal or positive fluorescence in situ&#xD;
             hybridization (FISH) result by 2013 American Society of Clinical Oncology&#xD;
             (ASCO)/Corrective Action Plan (CAP) guideline.&#xD;
&#xD;
          -  Patients must have measurable disease, per Response Evaluation Criteria in Solid&#xD;
             Tumors (RECIST) 1.1.&#xD;
&#xD;
        Part I Eligibility&#xD;
&#xD;
          -  Naive to trastuzumab (Herceptin), pertuzumab (Perjeta) and lapatinib (Tykerb),&#xD;
             ado-trastuzumab emtansine (Kadcyla) or other HER2-directed therapies.&#xD;
&#xD;
          -  Malignancy as follows:&#xD;
&#xD;
          -  Malignant soft tissue and bone tumors and recurrent or progressive, metastatic solid&#xD;
             tumors who have progressed on standard therapies; or,&#xD;
&#xD;
          -  Bladder cancer in the adjuvant setting (adjuvant bladder cancer patients):&#xD;
&#xD;
               -  Tumor stage T3a, T3b, T4a, T4b and any node positive disease regardless of tumor&#xD;
                  stage.&#xD;
&#xD;
               -  Status-post primary cystectomy with curative intent.&#xD;
&#xD;
               -  May or may not have received neoadjuvant cisplatin-based combination chemotherapy&#xD;
                  per National Comprehensive Cancer Network (NCCN) guidelines.&#xD;
&#xD;
               -  May or may not have received adjuvant radiotherapy or chemotherapy based on&#xD;
                  pathologic risk per NCCN guidelines.&#xD;
&#xD;
               -  Greater than or equal to 6 weeks s/p primary surgery with curative intent.&#xD;
&#xD;
          -  NOTE: Patients with breast, ovarian, cervical, colon, gastric/gastroesophageal&#xD;
             junction, non-small cell lung, renal cell, bladder, malignant soft tissue and bone&#xD;
             tumor, prostate cancer or other solid tumors.&#xD;
&#xD;
        Part II Eligibility&#xD;
&#xD;
          -  Malignant soft tissue and bone tumors and recurrent or progressive, metastatic solid&#xD;
             tumors who have progressed on standard therapies.&#xD;
&#xD;
          -  Recurrent or progressive metastatic disease after standard of care HER2-targeted&#xD;
             therapies, i.e., trastuzumab (Herceptin), pertuzumab (Perjeta), lapatinib (Tykerb),&#xD;
             ado-trastuzumab emtansine (TDM1) (Kadcyla) or other HER2-directed therapies.&#xD;
&#xD;
          -  Stable, concurrent use of tamoxifen or aromatase inhibitors for hormone receptor&#xD;
             positive breast cancer is permitted.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Pregnant women are excluded from this study because Adenoviral Transduced Autologous&#xD;
             Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine may have&#xD;
             the potential for teratogenic or abortifacient effects. Because there is an unknown&#xD;
             but potential risk for adverse events in nursing infants secondary to treatment of the&#xD;
             mother with AdHER DC vaccine, breastfeeding should be discontinued if the mother is&#xD;
             treated with AdHER DC vaccine.&#xD;
&#xD;
          -  Patients with active central nervous system (CNS) metastases or leptomeningeal&#xD;
             involvement by tumor (patients with a history of brain metastases who have&#xD;
             successfully treated for brain metastasis by surgery or radiation and who have not had&#xD;
             any evidence of the new or progressive CNS disease for more than 12 months are&#xD;
             eligible).&#xD;
&#xD;
          -  Patients with rapidly progressing disease in the opinion of the Principal&#xD;
             Investigator.&#xD;
&#xD;
          -  Patients with inadequate bilateral peripheral venous or central venous catheter access&#xD;
             for the required apheresis to allow generation of the autologous AdHER2 DC vaccine&#xD;
             product.&#xD;
&#xD;
          -  Clinically significant cardiac dysfunction defined as a history of &gt; New York Heart&#xD;
             Association (NYHA) Class II symptoms, angina, congestive heart failure, myocardial&#xD;
             infarction, arrhythmias or cardiac dysfunction requiring treatment or discontinuation&#xD;
             of chemotherapy.&#xD;
&#xD;
          -  History of changes in baseline LVEF that occurred during prior treatment with&#xD;
             anti-HER2 treatment.&#xD;
&#xD;
          -  Cumulative doxorubicin dose &gt; 400mg/m^2 (&gt;450 mg/m^2 for malignant soft tissue and&#xD;
             bone tumor patients) or cumulative epirubicin dose &gt; 800mg/m^2.&#xD;
&#xD;
          -  Use of any standard chemotherapy or other investigational agent(s) within 1 week of&#xD;
             study enrollment.&#xD;
&#xD;
          -  Use of systemic corticosteroid therapy within 2 weeks of study enrollment, including&#xD;
             patients receiving replacement corticosteroid therapy. Note: only topical, inhaled and&#xD;
             intranasal steroid therapy is permitted.&#xD;
&#xD;
          -  Active systemic viral, bacterial or fungal infection requiring treatment.&#xD;
&#xD;
          -  A medical history which the treating physician believes causes the patient to be&#xD;
             excluded. This includes a remote history of cancer. Please note: Squamous cell&#xD;
             carcinoma, basal cell carcinoma and remote history of cancer with no evidence of&#xD;
             recurrence for the past 5 years are eligible.&#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>Hoyoung M Maeng, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center, 9000 Rockville Pike</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2013-C-0016.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <reference>
    <citation>Moasser MM. The oncogene HER2: its signaling and transforming functions and its role in human cancer pathogenesis. Oncogene. 2007 Oct 4;26(45):6469-87. doi: 10.1038/sj.onc.1210477. Epub 2007 Apr 30.</citation>
    <PMID>17471238</PMID>
  </reference>
  <reference>
    <citation>Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan 1;25(1):118-45. doi: 10.1200/JCO.2006.09.2775. Epub 2006 Dec 11.</citation>
    <PMID>17159189</PMID>
  </reference>
  <reference>
    <citation>Lan KH, Lu CH, Yu D. Mechanisms of trastuzumab resistance and their clinical implications. Ann N Y Acad Sci. 2005 Nov;1059:70-5. doi: 10.1196/annals.1339.026.</citation>
    <PMID>16382045</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>August 12, 2022</results_first_submitted>
  <results_first_submitted_qc>August 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 10, 2022</results_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cancer Institute (NCI)</investigator_affiliation>
    <investigator_full_name>Hoyoung M. Maeng, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Metastatic Solid Tumors</keyword>
  <keyword>Human Epidermal Growth Factor Receptor 2 Expression (HER2/neu)</keyword>
  <keyword>Trastuzumab Exposure</keyword>
  <keyword>Dendritic Cell Vaccine</keyword>
  <keyword>Breast Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mitogens</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Clinical data available during the study and indefinitely.</ipd_time_frame>
    <ipd_access_criteria>Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT01730118/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Standard Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT01730118/ICF_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form: Addendum to 13C0016 Consent</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT01730118/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
5x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="P2">
          <title>Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
10x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="P3">
          <title>Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="P4">
          <title>Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="P5">
          <title>Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="P6">
          <title>Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="P7">
          <title>Enrolled But Not Treated</title>
          <description>Participants were enrolled on the study but not treated.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Dose Escalation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death on study</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Died before treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Chose to start a different treatment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression prior to treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Dose Expansion</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other medical condition</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Inability to return</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
5x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="B2">
          <title>Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
10x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="B3">
          <title>Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="B4">
          <title>Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="B5">
          <title>Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="B6">
          <title>Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="B7">
          <title>Enrolled But Not Treated</title>
          <description>Participants were enrolled on the study but not treated.</description>
        </group>
        <group group_id="B8">
          <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="6"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="3"/>
            <count group_id="B7" value="2"/>
            <count group_id="B8" value="33"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="48.28" spread="10.21"/>
                    <measurement group_id="B2" value="57.1" spread="7.92"/>
                    <measurement group_id="B3" value="64.5" spread="6.3"/>
                    <measurement group_id="B4" value="62.65" spread="5.08"/>
                    <measurement group_id="B5" value="60.03" spread="2.11"/>
                    <measurement group_id="B6" value="56.33" spread="7.62"/>
                    <measurement group_id="B7" value="63.9" spread="11.74"/>
                    <measurement group_id="B8" value="58.46" spread="8.89"/>
                  </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="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <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 group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </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="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Cardiac Toxicity</title>
        <description>Cardiac toxicity defined as cardiac dysfunction due to damage to the heart muscles or valves. Cardiac toxicity was assessed by serial echocardiography to determine left ventricular ejection fraction (LVEF) at baseline and following receipt of the last dose of vaccine. Cardiac toxicity is at least a 10% decline from the baseline in cardiac function. Normal LVEF is &gt;-53%. Below 53% is a cardiac dysfunction.</description>
        <time_frame>Baseline through receipt of last dose of vaccine, up to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
5x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O2">
            <title>Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
10x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O3">
            <title>Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O4">
            <title>Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O5">
            <title>Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O6">
            <title>Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Cardiac Toxicity</title>
          <description>Cardiac toxicity defined as cardiac dysfunction due to damage to the heart muscles or valves. Cardiac toxicity was assessed by serial echocardiography to determine left ventricular ejection fraction (LVEF) at baseline and following receipt of the last dose of vaccine. Cardiac toxicity is at least a 10% decline from the baseline in cardiac function. Normal LVEF is &gt;-53%. Below 53% is a cardiac dysfunction.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Normal LVEF &gt;-53%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac Dysfunction - LVEF below 53%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Develop at Least a 4-fold or 2.5- Fold Increase in Anti-Human Epidermal Growth Factor Receptor (HER2)/Neu Antibody Dilution Titers</title>
        <description>Vaccine immunogenicity was determined by the number of participants who develop at least a 4-fold increase in antibody dilution titers over baseline at the time points measured. The antibody response following the vaccination was assessed using peptide-array and reported as fold increase compared to the baseline values using the cut-off of 4 fold per study definition of the vaccine immunogenicity and also of 2.5 fold to aid the interpretation of the result.</description>
        <time_frame>Baseline through last dose of vaccine, up to 24 weeks</time_frame>
        <population>Not all participants had samples for analyses. Samples from 13 participants were analyzed in the following groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
5x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O2">
            <title>Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
10x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O3">
            <title>Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O4">
            <title>Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O5">
            <title>Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O6">
            <title>Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Develop at Least a 4-fold or 2.5- Fold Increase in Anti-Human Epidermal Growth Factor Receptor (HER2)/Neu Antibody Dilution Titers</title>
          <description>Vaccine immunogenicity was determined by the number of participants who develop at least a 4-fold increase in antibody dilution titers over baseline at the time points measured. The antibody response following the vaccination was assessed using peptide-array and reported as fold increase compared to the baseline values using the cut-off of 4 fold per study definition of the vaccine immunogenicity and also of 2.5 fold to aid the interpretation of the result.</description>
          <population>Not all participants had samples for analyses. Samples from 13 participants were analyzed in the following groups.</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="1"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>4-fold Increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2.5- fold Increase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)</title>
        <description>Number of participants who experienced tumor shrinkage or stabilization that is sufficient by modified immune response related criteria (irRC) to be considered stable disease (SD), a partial response (PR) or better (complete response (CR). SD is neither partial response nor progressive disease (PD). PR is ≥ 30% decrease in tumor burden compared with baseline, confirmation required. CR is disappearance of all target and non-target lesions. Lymph nodes must regress to &lt;10mm short axis. No new lesions, confirmation required. PD ≥ 20% increase in tumor burden compared with baseline, with nadir, or reset baseline. New lesions added to the tumor burden, confirmation required.</description>
        <time_frame>At 8, 16, 24, 36, 48, 76, 100, and 124 weeks after initial vaccination</time_frame>
        <population>Not all participants were available for analyses. Twenty one participants were evaluable.</population>
        <group_list>
          <group group_id="O1">
            <title>Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
5x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O2">
            <title>Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
10x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O3">
            <title>Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O4">
            <title>Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O5">
            <title>Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O6">
            <title>Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)</title>
          <description>Number of participants who experienced tumor shrinkage or stabilization that is sufficient by modified immune response related criteria (irRC) to be considered stable disease (SD), a partial response (PR) or better (complete response (CR). SD is neither partial response nor progressive disease (PD). PR is ≥ 30% decrease in tumor burden compared with baseline, confirmation required. CR is disappearance of all target and non-target lesions. Lymph nodes must regress to &lt;10mm short axis. No new lesions, confirmation required. PD ≥ 20% increase in tumor burden compared with baseline, with nadir, or reset baseline. New lesions added to the tumor burden, confirmation required.</description>
          <population>Not all participants were available for analyses. Twenty one participants were evaluable.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Stable Disease at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response at Week 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response at Week 16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response at Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease at Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response at Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response at Week 36</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease at Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response at Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response at Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease at Week 76</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response at Week 76</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response at Week 76</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease at Week 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response at Week 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response at Week 100</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease at Week 124</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response at Week 124</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complete Response at Week 124</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)</title>
        <description>Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</description>
        <time_frame>Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
5x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O2">
            <title>Part I Dose Escalation Level 2 - 10x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
10x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O3">
            <title>Part I Dose Escalation Level 3 - 520x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O4">
            <title>Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O5">
            <title>Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O6">
            <title>Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
            <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
          </group>
          <group group_id="O7">
            <title>Enrolled But Not Treated</title>
            <description>Participants were enrolled on the study but not treated.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)</title>
          <description>Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part I Dose Escalation Level 1 - 5x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
5x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="E2">
          <title>Part I Dose Escalation Level 2 -10x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
10x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="E3">
          <title>Part I Dose Escalation Level 3 - 20x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="E4">
          <title>Part II Dose Escalation Level 1 - 20x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
20x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="E5">
          <title>Part I Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="E6">
          <title>Part II Dose Expansion Cohort - 40x10^6 Total Nucleated Cells (TNCs)</title>
          <description>Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16, and 24 of study.&#xD;
40x10^6 Total Nucleated Cells (TNCs)</description>
        </group>
        <group group_id="E7">
          <title>Enrolled But Not Treated</title>
          <description>Participants were enrolled on the study but not treated.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</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="5" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Colonic obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Death NOS</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorders - Other, Biliary obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchial infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other, left renal abscess</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Serum amylase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="48" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumor pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary frequency</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary urgency</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="16" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="18" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAE (4.0)</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="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="30" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="27" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="30" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="36" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood and lymphatic system disorders - Other, Swollen lymph nodes. Left supraclavical area.</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cardiac disorders - Other, Mid RV dilation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Chest pain - cardiac</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blurred vision</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eye disorders - Other, Look like fleas/consult ophthalmology</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eye disorders - Other, Transient light flashes in eyes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eye disorders - Other, Specify</sub_title>
                <description>Transient visual field defect L eye associated with flashes, lasting &lt; 2 minutes.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" events="47" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="15" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Bloating</sub_title>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="10" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="20" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="10" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="15" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="9" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, Epigastric abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, Left sided abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Other, food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Malabsorption</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="13" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="18" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" events="13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="36" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rectal hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="24" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E3" events="13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Edema limbs</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="13" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="47" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E3" events="23" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" events="61" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" events="10" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Flu like symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="85" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E2" events="277" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E3" events="513" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E4" events="396" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" events="70" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" events="138" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="13" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="41" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="88" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" events="10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations - Other, Cyst R-scapular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Infections and infestations - Other, Pneumocystis carina pneumonia or PJP</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Serum amylase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="19" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="38" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="14" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="30" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="11" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="35" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="25" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>CPK increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="45" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="10" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="15" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="20" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="20" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="34" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="189" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E4" events="42" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" events="15" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="10" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Weight loss</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="21" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>White blood cell decreased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="30" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="10" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="21" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="32" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" events="15" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="10" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypercalcemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypermagnesemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperuricemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypoalbuminemia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="10" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyponatremia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypophosphatemia</sub_title>
                <counts group_id="E1" events="10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="62" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E4" events="57" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="24" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="20" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="21" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Chest wall pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="9" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="30" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="24" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorder - Other, Muscle spasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="24" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="26" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tumor pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="42" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" events="30" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Concentration impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="41" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Recurrent laryngeal nerve palsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="24" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" events="10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, Ciprofloxacine 250mg twice a day for 5 days</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Renal and urinary disorders - Other, Pyruria on Levaquin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="7" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="10" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Premature menopause</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Bronchial obstruction</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary hemorrhage</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="13" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="14" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="44" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="18" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" events="4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="54" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Postnasal drip</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="14" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="5" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders - Other, specify</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Voice alteration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="12" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, Specify</sub_title>
                <description>Itching around ears bilateral- Dr. Bronner's Magic Soaps</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, Left inguinal itch and redness.</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders - Other, Specify</sub_title>
                <description>Skin coloration change-Right arm. Patient reported noticing the change after 1st vaccine.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="10" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and medical procedures - Other, right nephrostomy placement, ureteroscopy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hot flashes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lymphocele</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Thromboembolic event</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" events="13" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Hoyoung Maeng</name_or_title>
      <organization>National Cancer Institute</organization>
      <phone>240-781-3253</phone>
      <email>hoyoung.maeng@nih.gov</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/NCT01730118
org study id: 130016
secondary id: 13-C-0016
nct id: NCT01730118
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Background:

      - Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu)/neu (HER2) is
      a tumor protein that appears in almost a third of breast cancers and in several other types
      of cancers such as colon, prostate and non-small cell lung. Tumors that overexpress HER2 can
      be associated with a more aggressive cancer, higher recurrence rates, and reduced survival
      rates. Researchers are testing a therapeutic cancer vaccine designed to stimulate the immune
      system to recognize HER2. The vaccine, called adenoviral transduced autologous human
      epidermal growth factor receptor (AdHER)/neu dendritic cell vaccine, is custom-made using an
      individual's own immune cells. These cells will be collected and used to produce the vaccine.

      Objectives:

      - To test the safety and effectiveness of AdHER2 vaccination.

      Eligibility:

      - Individuals at least 18 years of age who have HER2-expressing tumors.

      Design:

        -  Participants will be screened with a physical exam and medical history. Blood and urine
           samples will be collected. Imaging studies will also be performed.

        -  Participants will have an apheresis procedure to collect immune cells to create the
           vaccine.

        -  Participants will receive five doses of the vaccine at study Weeks 0, 4, 8, 16 and 24.

        -  Participants will be monitored with physical exams, frequent blood tests and imaging
           studies.
Background:

        -  Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu) is a
           proto-oncogene that encodes a 185-kd transmembrane tyrosine kinase receptor that
           participates in receptor-receptor interactions that regulate cell growth,
           differentiation and proliferation. Its over-expression contributes to neoplastic
           transformation.

        -  HER2 is over-expressed in up to 25-30% of node-positive or node-negative primary breast
           cancers and is associated with clinically aggressive breast cancer, a high recurrence
           rate and reduced survival.

        -  Trastuzumab (Herceptin (Registered trademark)) is a recombinant humanized mouse
           monoclonal antibody (MAb) that binds to the extracellular (EC) domain of the HER2
           receptor. Its clinical efficacy is limited to patients with 3+ HER2 tumor expression
           documented by immunohistochemistry (IHC) or a Vysis fluorescent in situ hybridization
           (FISH) ratio of greater than 2.2. IHC is a subjective measurement of HER2/neu protein
           while FISH is an objective measurement of amplification of the HER2 oncogene.

        -  Although the use of trastuzumab has been associated with improved clinical outcomes, a
           significant number of patients are unresponsive to therapy and most eventually
           experience clinical progression. At present no vaccine is available that induces
           patients to make their own anti-HER2 antibodies.

        -  We propose to investigate the use of an adenoviral vector (Ad5f35) expressing human
           HER2ECTM (Ad5f35HER2ECTM- AdHER2) to transduce autologous dendritic cells for
           therapeutic vaccination in patients with HER2 expressing solid tumors.

      Objectives:

      -To determine the safety and toxicity of autologous AdHER2 dendritic cell vaccination.

      Specifically, to determine if the fraction of patients with cancer therapeutics-related
      cardiac dysfunction (CTRCD), defined as a decrease in left ventricular ejection fraction
      (LVEF) >=10 percentage points, to a value LVEF to less than or equal to 53% (normal reference
      value for two-dimensional (2-D) echocardiography), is sufficiently low to warrant further
      development in subsequent trials.

      -To determine the immunogenicity of autologous AdHER2 dendritic cell vaccination as measured
      by a 3-fold increase in anti-HER2/neu antibody concentration or a 4-fold increase in antibody
      dilution titers over baseline.

      Study Design:

      Open label, non-randomized, two-part, phase I study of 48 weeks duration for evaluation of
      primary endpoints with extended follow-up out to 30 months to monitor LVEF cardiac function.

      Part I involves vaccine dose escalation in a population with no prior exposure to trastuzumab
      or other HER2-targeted therapies to determine if there is a significant, adverse safety
      signal regarding cardiac toxicity, in addition to preliminary assessment of the vaccine s
      immunogenicity and clinical activity. Five doses of 5, 10, 20 or 40 x 10(6) viable
      cells/AdHER2 DC vaccine will be given intradermally at Weeks 0, 4, 8, 16 and 24 in patients
      with metastatic solid tumors or high risk bladder cancer in the adjuvant setting Response
      will be evaluated by a Modified Immune- Related Response Criteria (irRC) based on Response
      Evaluation Criteria in Solid Tumors

      (Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (modified irRC) at Weeks 8, 16,
      24, 36 and 48 with confirmatory scans obtained not less than 4 weeks following initial
      documentation of objective response. Adjuvant bladder cancer patients will undergo re-staging
      at Weeks 8, 16, 24, 36 and 48 with confirmatory scans obtained not less than 4 weeks
      following initial documentation of objective response.

      Part II is identical to part I, in the schedule of treatment and response evaluation, but is
      conducted in a population with prior exposure to trastuzumab and other HER2-targeted
      therapies.

      Eligibility:

      Part I:

        -  Adults >= 18 with recurrent, metastatic solid tumors for whom trastuzumab is not
           clinically indicated in standard of care OR who are naive to HER2 targeted therapies:

        -  Patients with ovarian, cervical, colon, non-small cell lung, renal cell, bladder and
           prostate cancer, and malignant soft tissue and bone tumor or other solid tumors that is
           HER2 1+, 2+ or 3+ by IHC OR have a Vysis FISH result greater than or equal to 1.8.

             -  Patients with breast cancer that is HER2 1+ or 2+ by IHC or with a Vysis FISH
                result less than or equal to 1.8 - less than or equal to 2.2.

             -  Measurable disease, with the exception of metastatic bladder cancer patients that
                have completed first line chemotherapy and may not have measurable disease.

        -  Adults greater than or equal to 18 with HER2+ bladder cancer in the adjuvant setting

             -  Tumor stage T3a, T3b, T4a and T4b or any node positive disease.

             -  Tumors that are HER2 1+, 2+ or 3+ by IHC or have a Vysis FISH result greater than
                or equal to 1.8.

             -  greater than or equal to 6 weeks status post primary surgery with curative intent.

             -  Eastern Cooperative Oncology Group (ECOG) 0-1.

             -  Naive to trastuzumab, pertuzumab, lapatinib, ado-trastuzumab emtansine (TDM1) or
                other HER2-directed therapies.

      Part II:

        -  Adults >= 18 with breast, gastric or gastroesophageal junction or other cancers with 1+
           to 3+ HER2/neu expression by IHC or a Vysis FISH result > 2.2.

        -  Recurrent metastatic disease, ECOG 0-1. Disease progression following HER2-targeted
           therapies. i.e., trastuzumab, pertuzumab, lapatinib, ado-trastuzumab emtansine or other
           HER2 agents.

        -  Measurable disease.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Cardiac Toxicity
time frame: Baseline through receipt of last dose of vaccine, up to 24 weeks
description: Cardiac toxicity defined as cardiac dysfunction due to damage to the heart muscles or valves. Cardiac toxicity was assessed by serial echocardiography to determine left ventricular ejection fraction (LVEF) at baseline and following receipt of the last dose of vaccine. Cardiac toxicity is at least a 10% decline from the baseline in cardiac function. Normal LVEF is >-53%. Below 53% is a cardiac dysfunction.
measure: Number of Participants Who Develop at Least a 4-fold or 2.5- Fold Increase in Anti-Human Epidermal Growth Factor Receptor (HER2)/Neu Antibody Dilution Titers
time frame: Baseline through last dose of vaccine, up to 24 weeks
description: Vaccine immunogenicity was determined by the number of participants who develop at least a 4-fold increase in antibody dilution titers over baseline at the time points measured. The antibody response following the vaccination was assessed using peptide-array and reported as fold increase compared to the baseline values using the cut-off of 4 fold per study definition of the vaccine immunogenicity and also of 2.5 fold to aid the interpretation of the result.
measure: Number of Participants Who Experienced Tumor Shrinkage or Stabilization That is Sufficient by Modified Immune Response Related Criteria (irRC) to be Considered Stable Disease (SD), a Partial Response (PR) or Better (Complete Response (CR)
time frame: At 8, 16, 24, 36, 48, 76, 100, and 124 weeks after initial vaccination
description: Number of participants who experienced tumor shrinkage or stabilization that is sufficient by modified immune response related criteria (irRC) to be considered stable disease (SD), a partial response (PR) or better (complete response (CR). SD is neither partial response nor progressive disease (PD). PR is ≥ 30% decrease in tumor burden compared with baseline, confirmation required. CR is disappearance of all target and non-target lesions. Lymph nodes must regress to <10mm short axis. No new lesions, confirmation required. PD ≥ 20% increase in tumor burden compared with baseline, with nadir, or reset baseline. New lesions added to the tumor burden, confirmation required.
measure: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
time frame: Date treatment consent signed to date off study, approximately 29 months and 13 days, 28 months and 28 days, 40 months and 2 days, 24 months and 23 days, 25 months and 30 days, and 28 months and 3 days for each group respectively.
description: Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
arm group label: 1/Part I dose escalation
arm group type: Experimental
description: Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at escalating doses
arm group label: 2/Part I dose expansion
arm group type: Experimental
description: Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at a next lower dose or the highest dose
arm group label: 3/Part 1 dose escalation
arm group type: Experimental
description: Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at Dose Level 1
arm group label: 4/Part II dose escalation
arm group type: Experimental
description: Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at Dose Level 1
arm group label: 5/Part II dose expansion
arm group type: Experimental
description: Adenoviral Transduced Autologous Human epidermal growth factor receptor (AdHER) dendritic cell (DC) vaccine administered at Arm 1 maximum tolerated dose (MTD)
intervention type: Biological
intervention name: Adenoviral Transduced Autologous Human Epidermal Growth Factor Receptor (AdHER)2/neu Dendritic Cell (DC) Vaccine
description: autologous AdHER2 transduced dendritic cell vaccine manufactured under Good Manufacturing Practices (GMP) conditions from cryopreserved patient monocytes here at the National Institutes of Health (NIH) Clinical Center (CC) Department of Transfusion Medicine (DTM). Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16 and 24 of the study.
arm group label: 1/Part I dose escalation
arm group label: 2/Part I dose expansion
arm group label: 3/Part 1 dose escalation
arm group label: 4/Part II dose escalation
arm group label: 5/Part II dose expansion
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hoyoung M Maeng, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2013-C-0016.html
description: NIH Clinical Center Detailed Web Page
citation: Moasser MM. The oncogene HER2: its signaling and transforming functions and its role in human cancer pathogenesis. Oncogene. 2007 Oct 4;26(45):6469-87. doi: 10.1038/sj.onc.1210477. Epub 2007 Apr 30.
PMID: 17471238
citation: Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan 1;25(1):118-45. doi: 10.1200/JCO.2006.09.2775. Epub 2006 Dec 11.
PMID: 17159189
citation: Lan KH, Lu CH, Yu D. Mechanisms of trastuzumab resistance and their clinical implications. Ann N Y Acad Sci. 2005 Nov;1059:70-5. doi: 10.1196/annals.1339.026.
PMID: 16382045
responsible party type: Principal Investigator
investigator affiliation: National Cancer Institute (NCI)
investigator full name: Hoyoung M. Maeng, M.D.
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Mitogens
sharing ipd: Yes
ipd description: All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request. All collected IPD will be shared with collaborators under the terms of collaborative agreements.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Clinical data available during the study and indefinitely.
ipd access criteria: Clinical data will be made available via subscription to Biomedical Translational Research Information System (BTRIS) and with the permission of the study principal investigator (PI).
provided document: 
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 