<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/NCT02992743</url>
  </required_header>
  <id_info>
    <org_study_id>208469</org_study_id>
    <secondary_id>ADP-0011-007</secondary_id>
    <nct_id>NCT02992743</nct_id>
  </id_info>
  <brief_title>Letetresgene Autoleucel Engineered T Cells in NY-ESO-1 Positive Participants With Advanced Myxoid/ Round Cell Liposarcoma</brief_title>
  <official_title>A Pilot Study of NY-ESO-1c259T Cells in Subjects With Advanced Myxoid/ Round Cell Liposarcoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</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>
      This trial will evaluate safety and efficacy of Letetresgene autoleucel (GSK3377794) in&#xD;
      participants with advanced myxoid/round cell liposarcoma or high-grade myxoid liposarcoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins&#xD;
      that have been found in several tumor types. Clinical trials using adoptively transferred&#xD;
      T-cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene&#xD;
      autoleucel (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor (TCR)&#xD;
      engineered T-cells. This protocol investigates Letetresgene autoleucel treatment in Human&#xD;
      Leukocyte Antigen (HLA)-A*02+ participants with NY-ESO1+ advanced myxoid/round cell&#xD;
      liposarcoma or high-grade myxoid liposarcoma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">March 22, 2022</completion_date>
  <primary_completion_date type="Actual">November 1, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] &gt; Confirmed Partial Response [PR] &gt; Stable Disease [SD] &gt; Progressive Disease [PD] &gt; Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by the investigator per RECIST v1.1 Criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR) Assessed by Investigator</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) Assessed by Investigator</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) Assessed by Investigator</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] &gt; Confirmed Partial Response [PR] &gt; Stable Disease [SD] &gt; Progressive Disease [PD] &gt; Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by independent reviewer per RECIST v1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via independent reviewer assessment per RECIST v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR) Assessed by Independent Reviewer</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) Assessed by Independent Reviewer</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) Assessed by Independent Reviewer</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by independent reviewer per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Event of Special Interest (AESI)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. The AESI included events of Cytokine release syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus host disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), and Guillain-Barre syndrome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Grade Increase in Hematology Results at Worst-case Post-baseline</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Grade Increase in Clinical Chemistry Results at Worst-case Post-baseline</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Blood samples were collected for the analysis clinical chemistry parameters: glucose, albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, sodium, phosphate, calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Replication Competent Lentivirus (RCL)</measure>
    <time_frame>Day 1 (pre-infusion), and at Week 12, Week 24, and 1 year post-infusion</time_frame>
    <description>RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Insertional Oncogenesis</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Peripheral blood mononuclear cells (PBMC) samples were collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. DNA from participant identified with &gt;1% PBMC at &gt;=1 year post T-cell infusion was sent for integration site analysis. Integration site analysis was used to assess the possibility of insertional oncogenesis. Participants with insertional oncogenesis were participants with any clones representing &gt;20% of the total.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Anti-drug Antibodies (ADAs)</measure>
    <time_frame>Up to 24 Months</time_frame>
    <description>Serum samples were collected to analyze for the presence of ADAs using validated immunoassays.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Transgene Expansion (Cmax) of GSK3377794</measure>
    <time_frame>Day 2 to Day 15</time_frame>
    <description>Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Cmax (Tmax)</measure>
    <time_frame>Day 2 to Day 15</time_frame>
    <description>Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Electrocardiogram (ECG) Parameters- PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval</measure>
    <time_frame>Baseline, Day 1, Day 4 and Day 8</time_frame>
    <description>Triplicate 12-Lead ECGs were collected at baseline visit and single ECGs at other timepoints. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in ECG Mean Heart Rate</measure>
    <time_frame>Baseline, Day 1 (Pre-dose), Day 4 and Day 8</time_frame>
    <description>Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>letetresgene autoleucel (GSK3377794)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive letetresgene autoleucel (GSK3377794), as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>letetresgene autoleucel (GSK3377794)</intervention_name>
    <description>Letetresgene autoleucel (GSK3377794) as an IV infusion.</description>
    <arm_group_label>letetresgene autoleucel (GSK3377794)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Cyclophosphamide will be used as a lymphodepleting chemotherapy.</description>
    <arm_group_label>letetresgene autoleucel (GSK3377794)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>Fludarabine will be used as a lymphodepleting chemotherapy.</description>
    <arm_group_label>letetresgene autoleucel (GSK3377794)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant is greater than equal to (&gt;=)18 years of age at the time of signing the&#xD;
             study informed consent.&#xD;
&#xD;
          -  Participant has a diagnosis of advanced (metastatic or inoperable) high grade myxoid&#xD;
             liposarcoma / myxoid round cell liposarcoma confirmed histologically and by the&#xD;
             presence of the reciprocal chromosomal translocation t(12;16) (q13;p11) or t(12; 22)&#xD;
             (q13;q12).&#xD;
&#xD;
          -  Participant has measurable disease according to RECIST v1.1 criteria.&#xD;
&#xD;
          -  Participant must have previously received or be intolerant to anthracycline based&#xD;
             therapy for advanced (metastatic or inoperable) disease.&#xD;
&#xD;
          -  Participants who received neoadjuvant/adjuvant anthracycline based therapy and&#xD;
             progressed within 6 months of completion of therapy will be eligible.&#xD;
&#xD;
          -  Participant must be HLA A*02:01, HLA A*02:05 and/or HLA-A*02:06 positive.&#xD;
&#xD;
          -  Participant's tumor (either the most recent archival specimen or a fresh biopsy) is&#xD;
             positive for NY-ESO-1 expression by a designated central laboratory.&#xD;
&#xD;
          -  Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.&#xD;
&#xD;
          -  Participant has a left ventricular ejection fraction &gt;=45%.&#xD;
&#xD;
          -  Participant is fit for apheresis and has adequate venous access for the cell&#xD;
             collection.&#xD;
&#xD;
          -  Participants must satisfy pregnancy and contraceptive requirements per protocol and&#xD;
             have adequate organ function per protocol specified values.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any previous gene therapy using an integrating vector.&#xD;
&#xD;
          -  Any previous allogeneic hematopoietic stem cell transplant.&#xD;
&#xD;
          -  Participant has history of allergic reactions attributed to compounds of similar&#xD;
             chemical or biologic composition to fludarabine, cyclophosphamide or other agents used&#xD;
             in the study.&#xD;
&#xD;
          -  Participant has history of chronic or recurrent (within the last year prior to&#xD;
             screening) severe autoimmune or immune mediated disease requiring steroids or other&#xD;
             immunosuppressive treatments.&#xD;
&#xD;
          -  Participant has known active brain or leptomeningeal metastases.&#xD;
&#xD;
          -  Participant has other prior malignancy that is not in complete remission.&#xD;
&#xD;
          -  Participant has uncontrolled intercurrent illness including, but not limited to:&#xD;
&#xD;
          -  (i) Ongoing or active infection.&#xD;
&#xD;
          -  (ii) Clinically significant cardiac disease&#xD;
&#xD;
          -  (iii) Interstitial lung disease (participants with existing pneumonitis as a result of&#xD;
             radiation are not excluded, however, participants must not be oxygen dependent).&#xD;
&#xD;
          -  Participant has active infection with Human Immunodeficiency Virus (HIV), Hepatitis B&#xD;
             virus (HBV), ), Hepatitis C virus (HCV) or human T-lymphotropic virus (HTLV).&#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>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <results_first_submitted>October 31, 2022</results_first_submitted>
  <results_first_submitted_qc>October 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">November 28, 2022</results_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Myxoid/ round cell liposarcoma</keyword>
  <keyword>Letetresgene autoleucel</keyword>
  <keyword>Immuno-oncology</keyword>
  <keyword>T Cell Receptor</keyword>
  <keyword>Leukapheresis</keyword>
  <keyword>NY-ESO-1</keyword>
  <keyword>Adoptive TCR T-cell therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liposarcoma</mesh_term>
    <mesh_term>Liposarcoma, Myxoid</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cyclophosphamide</mesh_term>
    <mesh_term>Fludarabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD for this study will be made available via the Clinical Study Data Request site.</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_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.</ipd_time_frame>
    <ipd_access_criteria>Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.</ipd_access_criteria>
    <ipd_url>http://clinicalstudydatarequest.com</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT02992743/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 5, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT02992743/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was an open-label study evaluating the safety and tolerability of autologous T-Cells expressing enhanced T-cell receptors (TCRs) specific for New York esophageal squamous cell carcinoma (NY-ESO)-1 (letetresgene autoleucel, lete-cel, GSK3377794) in Human Leukocyte Antigen (HLA)-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with Advanced Myxoid/ Round Cell Liposarcoma.</recruitment_details>
      <pre_assignment_details>A total of 23 participants were enrolled in this study. Out of 23 participants, 20 participants received NY-ESO-1c259 T cell infusion.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
          <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 milligrams per meter square per day (mg/m^2/day) plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
          <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received T-cell Infusion</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9">5 participants were transferred to separate long term follow-up study 208750 (NCT03391778) and 4 participants died.</participants>
                <participants group_id="P2" count="8">8 participants were transferred to separate long term follow-up study 208750 (NCT03391778).</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death-Prior to T-Cell Infusion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did Not Meet Inclusion/Exclusion</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No measurable disease</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
          <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
        </group>
        <group group_id="B2">
          <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
          <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>YEARS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.0" spread="6.79"/>
                    <measurement group_id="B2" value="46.0" spread="11.61"/>
                    <measurement group_id="B3" value="48.3" spread="9.19"/>
                  </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="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other: More than one race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment</title>
        <description>Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment</title>
          <description>Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.</description>
          <population>Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="2.5" upper_limit="55.6"/>
                    <measurement group_id="O2" value="40" lower_limit="12.2" upper_limit="73.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment</title>
        <description>The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] &gt; Confirmed Partial Response [PR] &gt; Stable Disease [SD] &gt; Progressive Disease [PD] &gt; Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by the investigator per RECIST v1.1 Criteria.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment</title>
          <description>The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] &gt; Confirmed Partial Response [PR] &gt; Stable Disease [SD] &gt; Progressive Disease [PD] &gt; Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by the investigator per RECIST v1.1 Criteria.</description>
          <population>Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794.</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Response (CR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response (PR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease (SD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease (PD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Evaluable (NE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response (TTR) Assessed by Investigator</title>
        <description>Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by investigator assessment were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Response (TTR) Assessed by Investigator</title>
          <description>Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by investigator assessment were included in this analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.856" lower_limit="0.920" upper_limit="2.793"/>
                    <measurement group_id="O2" value="1.938" lower_limit="1.889" upper_limit="2.366"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) Assessed by Investigator</title>
        <description>Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by investigator assessment were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) Assessed by Investigator</title>
          <description>Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by investigator assessment were included in this analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.31" lower_limit="1.87" upper_limit="8.74"/>
                    <measurement group_id="O2" value="7.47" lower_limit="6.01" upper_limit="NA">Statistics that cannot be calculated due to insufficient events are presented as &quot;NA&quot;</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) Assessed by Investigator</title>
        <description>Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) Assessed by Investigator</title>
          <description>Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.36" lower_limit="2.00" upper_limit="11.50"/>
                    <measurement group_id="O2" value="8.74" lower_limit="0.89" upper_limit="NA">Statistics that cannot be calculated due to insufficient events are presented as &quot;NA&quot;</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment</title>
        <description>The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] &gt; Confirmed Partial Response [PR] &gt; Stable Disease [SD] &gt; Progressive Disease [PD] &gt; Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by independent reviewer per RECIST v1.1 criteria.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment</title>
          <description>The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] &gt; Confirmed Partial Response [PR] &gt; Stable Disease [SD] &gt; Progressive Disease [PD] &gt; Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by independent reviewer per RECIST v1.1 criteria.</description>
          <population>Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794.</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete Response (CR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial Response (PR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease (SD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease (PD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Evaluable (NE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer</title>
        <description>Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via independent reviewer assessment per RECIST v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer</title>
          <description>Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via independent reviewer assessment per RECIST v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.</description>
          <population>Modified Intent-to-Treat (mITT) population, which included all participants who underwent leukapheresis and received GSK3377794.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="2.5" upper_limit="55.6"/>
                    <measurement group_id="O2" value="40" lower_limit="12.2" upper_limit="73.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response (TTR) Assessed by Independent Reviewer</title>
        <description>Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by independent reviewer were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Response (TTR) Assessed by Independent Reviewer</title>
          <description>Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by independent reviewer were included in this analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.366" lower_limit="1.840" upper_limit="2.891"/>
                    <measurement group_id="O2" value="1.889" lower_limit="1.413" upper_limit="1.938"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) Assessed by Independent Reviewer</title>
        <description>Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by independent reviewer were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) Assessed by Independent Reviewer</title>
          <description>Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;)10 mm. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only responders by independent reviewer were included in this analysis.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Statistics that cannot be calculated due to insufficient events are presented as &quot;NA&quot;</measurement>
                    <measurement group_id="O2" value="7.16" lower_limit="4.57" upper_limit="NA">Statistics that cannot be calculated due to insufficient events are presented as &quot;NA&quot;</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) Assessed by Independent Reviewer</title>
        <description>Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by independent reviewer per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) Assessed by Independent Reviewer</title>
          <description>Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by independent reviewer per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.67" lower_limit="2.79" upper_limit="NA">Statistics that cannot be calculated due to insufficient events are presented as &quot;NA&quot;</measurement>
                    <measurement group_id="O2" value="9.03" lower_limit="5.32" upper_limit="NA">Statistics that cannot be calculated due to insufficient events are presented as &quot;NA&quot;</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs</title>
        <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Intent-to-Treat (ITT) Population, which included all participants who underwent leukapheresis.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs</title>
          <description>An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above.</description>
          <population>Intent-to-Treat (ITT) Population, which included all participants who underwent leukapheresis.</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="13"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Event of Special Interest (AESI)</title>
        <description>An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. The AESI included events of Cytokine release syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus host disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), and Guillain-Barre syndrome.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Event of Special Interest (AESI)</title>
          <description>An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. The AESI included events of Cytokine release syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus host disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), and Guillain-Barre syndrome.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with any AESI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cytokine release syndrome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haematopoietic cytopenias (including pancytopenia and aplastic anaemia)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Grade Increase in Hematology Results at Worst-case Post-baseline</title>
        <description>Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Grade Increase in Hematology Results at Worst-case Post-baseline</title>
          <description>Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocyte count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Grade Increase in Clinical Chemistry Results at Worst-case Post-baseline</title>
        <description>Blood samples were collected for the analysis clinical chemistry parameters: glucose, albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, sodium, phosphate, calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented.</description>
        <time_frame>Up to 24 months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Grade Increase in Clinical Chemistry Results at Worst-case Post-baseline</title>
          <description>Blood samples were collected for the analysis clinical chemistry parameters: glucose, albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, sodium, phosphate, calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.</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="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Glucose Hyperglycemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose Hypoglycemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium Hyperkalemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium Hypokalemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium Hypermagnesemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium Hypomagnesemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium Hypernatremia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium Hyponatremia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium Corrected for Albumin Hypercalcemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium Corrected for Albumin Hypocalcemia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Replication Competent Lentivirus (RCL)</title>
        <description>RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G).</description>
        <time_frame>Day 1 (pre-infusion), and at Week 12, Week 24, and 1 year post-infusion</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.. Only those participants with RCL assessed post T-cell infusion were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Replication Competent Lentivirus (RCL)</title>
          <description>RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G).</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794.. Only those participants with RCL assessed post T-cell infusion were included in the analysis.</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="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Insertional Oncogenesis</title>
        <description>Peripheral blood mononuclear cells (PBMC) samples were collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. DNA from participant identified with &gt;1% PBMC at &gt;=1 year post T-cell infusion was sent for integration site analysis. Integration site analysis was used to assess the possibility of insertional oncogenesis. Participants with insertional oncogenesis were participants with any clones representing &gt;20% of the total.</description>
        <time_frame>Up to 2 years</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Number of participants analyzed comprises participants for whom integration site analysis was conducted.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Insertional Oncogenesis</title>
          <description>Peripheral blood mononuclear cells (PBMC) samples were collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. DNA from participant identified with &gt;1% PBMC at &gt;=1 year post T-cell infusion was sent for integration site analysis. Integration site analysis was used to assess the possibility of insertional oncogenesis. Participants with insertional oncogenesis were participants with any clones representing &gt;20% of the total.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Number of participants analyzed comprises participants for whom integration site analysis was conducted.</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="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Anti-drug Antibodies (ADAs)</title>
        <description>Serum samples were collected to analyze for the presence of ADAs using validated immunoassays.</description>
        <time_frame>Up to 24 Months</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with post-baseline ADA results were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-drug Antibodies (ADAs)</title>
          <description>Serum samples were collected to analyze for the presence of ADAs using validated immunoassays.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with post-baseline ADA results were analyzed.</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="7"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Transgene Expansion (Cmax) of GSK3377794</title>
        <description>Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax.</description>
        <time_frame>Day 2 to Day 15</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Transgene Expansion (Cmax) of GSK3377794</title>
          <description>Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Copies per microgram genomic DNA</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66991.71" spread="127.0"/>
                    <measurement group_id="O2" value="108485.91" spread="53.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Cmax (Tmax)</title>
        <description>Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax.</description>
        <time_frame>Day 2 to Day 15</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Cmax (Tmax)</title>
          <description>Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="2" upper_limit="13"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794</title>
        <description>Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).</description>
        <time_frame>Up to 28 days</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794</title>
          <description>Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Days*copies per microgram genomic DNA</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="727135.6" spread="223.9"/>
                    <measurement group_id="O2" value="1142798.27" spread="70.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Electrocardiogram (ECG) Parameters- PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval</title>
        <description>Triplicate 12-Lead ECGs were collected at baseline visit and single ECGs at other timepoints. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value.</description>
        <time_frame>Baseline, Day 1, Day 4 and Day 8</time_frame>
        <population>Modified Intent-to-Treat (mITT) population. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Electrocardiogram (ECG) Parameters- PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval</title>
          <description>Triplicate 12-Lead ECGs were collected at baseline visit and single ECGs at other timepoints. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value.</description>
          <population>Modified Intent-to-Treat (mITT) population. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Milliseconds (msec)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PR Interval, BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.9" spread="14.59"/>
                    <measurement group_id="O2" value="142" spread="12.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval, DAY 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="8.66"/>
                    <measurement group_id="O2" value="-2.2" spread="9.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval, DAY 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.7" spread="17.18"/>
                    <measurement group_id="O2" value="-4" spread="12.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval, DAY 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.1" spread="14.9"/>
                    <measurement group_id="O2" value="1" spread="9.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration, BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.2" spread="16.53"/>
                    <measurement group_id="O2" value="86.1" spread="15.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration, DAY 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="18.87"/>
                    <measurement group_id="O2" value="0.9" spread="6.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration, DAY 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="20.43"/>
                    <measurement group_id="O2" value="0.8" spread="5.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration, DAY 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="25.75"/>
                    <measurement group_id="O2" value="-1" spread="5.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval, BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="401.1" spread="11.71"/>
                    <measurement group_id="O2" value="389.3" spread="33.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval, DAY 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.4" spread="23.51"/>
                    <measurement group_id="O2" value="-8.1" spread="33.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval, DAY 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-49.4" spread="38.59"/>
                    <measurement group_id="O2" value="-72.5" spread="47.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval, DAY 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.7" spread="21.63"/>
                    <measurement group_id="O2" value="-4.4" spread="43.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB Interval, BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="427" spread="4.24"/>
                    <measurement group_id="O2" value="423.3" spread="19.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB Interval, DAY 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="NA">Number of Participants analyzed was 1 only.</measurement>
                    <measurement group_id="O2" value="36.3" spread="34.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB Interval, DAY 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" spread="24.04"/>
                    <measurement group_id="O2" value="8" spread="25.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcB Interval, DAY 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="NA">Number of Participants analyzed was 1 only.</measurement>
                    <measurement group_id="O2" value="47" spread="50.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval, BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="429.9" spread="23.75"/>
                    <measurement group_id="O2" value="425.3" spread="16.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval, DAY 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.1" spread="21.06"/>
                    <measurement group_id="O2" value="1.3" spread="17.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval, DAY 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.3" spread="36.62"/>
                    <measurement group_id="O2" value="3.3" spread="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTcF Interval, DAY 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="22.63"/>
                    <measurement group_id="O2" value="16.2" spread="39.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Interval, BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="842.6" spread="144.62"/>
                    <measurement group_id="O2" value="807.6" spread="166.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Interval, DAY 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-15.8" spread="98.77"/>
                    <measurement group_id="O2" value="5.3" spread="43.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Interval, DAY 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-162.5" spread="179.21"/>
                    <measurement group_id="O2" value="-188" spread="11.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RR Interval, DAY 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-71.6" spread="109.66"/>
                    <measurement group_id="O2" value="-138.5" spread="77.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in ECG Mean Heart Rate</title>
        <description>Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value.</description>
        <time_frame>Baseline, Day 1 (Pre-dose), Day 4 and Day 8</time_frame>
        <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
            <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in ECG Mean Heart Rate</title>
          <description>Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value.</description>
          <population>Modified Intent-to-Treat (mITT) population which included all participants who underwent leukapheresis and received GSK3377794. Only those participants with data available at the specified data points were analyzed.</population>
          <units>Beats per minute (beats/minute)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BASELINE</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.0" spread="12.34"/>
                    <measurement group_id="O2" value="78.0" spread="20.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="10.08"/>
                    <measurement group_id="O2" value="4.8" spread="14.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1" spread="16.34"/>
                    <measurement group_id="O2" value="38.9" spread="21.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAY 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="12.72"/>
                    <measurement group_id="O2" value="9.1" spread="16.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 30 months.</time_frame>
      <desc>All cause mortality, SAEs and non-serious adverse events were reported for the Intent-to-Treat (ITT) population, which included all participants who underwent leukapheresis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Reduced Lymphodepletion Dose Plus GSK3377794</title>
          <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1c259 T cell receptors (TCR) bearing T-cells. Participants underwent lymphodepleting chemotherapy; cyclophosphamide 600 mg/m^2/day plus fludarabine 30 mg/m^2/day on day -7 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
        </group>
        <group group_id="E2">
          <title>Standard Lymphodepletion Dose Plus GSK3377794</title>
          <description>Eligible participants were leukapheresed to manufacture autologous NY-ESO-1^c259 TCR bearing T-cells. Participants underwent lymphodepleting chemotherapy consisting of cyclophosphamide 900 mg/m^2/day starting on day -7 through day -5 plus fludarabine 30 mg/m^2/day on day -8 through day -5 followed by a single infusion of GSK3377794 on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24.1</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="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </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="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24.1</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="13" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Supraventricular extrasystoles</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Euthyroid sick syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eye oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="11" subjects_affected="8" subjects_at_risk="13"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="10" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Catheter site related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="13"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="13"/>
                <counts group_id="E2" events="13" subjects_affected="8" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ocular icterus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Culture urine positive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Electrocardiogram abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="24" subjects_affected="10" subjects_at_risk="13"/>
                <counts group_id="E2" events="19" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="13"/>
                <counts group_id="E2" events="18" subjects_affected="8" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="13"/>
                <counts group_id="E2" events="23" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="13"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bursa disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases to skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Phantom limb syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </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="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinus pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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="3" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyshidrotic eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nail ridging</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="13"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="13"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Jugular vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
      <email>GSKClinicalSupportHD@gsk.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02992743
org study id: 208469
secondary id: ADP-0011-007
nct id: NCT02992743
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial will evaluate safety and efficacy of Letetresgene autoleucel (GSK3377794) in
      participants with advanced myxoid/round cell liposarcoma or high-grade myxoid liposarcoma.
New York esophageal antigen-1 (NY-ESO-1) and LAGE-1a antigens are tumor-associated proteins
      that have been found in several tumor types. Clinical trials using adoptively transferred
      T-cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene
      autoleucel (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor (TCR)
      engineered T-cells. This protocol investigates Letetresgene autoleucel treatment in Human
      Leukocyte Antigen (HLA)-A*02+ participants with NY-ESO1+ advanced myxoid/round cell
      liposarcoma or high-grade myxoid liposarcoma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment
time frame: Up to 24 months
description: Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.
measure: Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment
time frame: Up to 24 months
description: The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] > Confirmed Partial Response [PR] > Stable Disease [SD] > Progressive Disease [PD] > Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by the investigator per RECIST v1.1 Criteria.
measure: Time to Response (TTR) Assessed by Investigator
time frame: Up to 24 months
description: Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm.
measure: Duration of Response (DOR) Assessed by Investigator
time frame: Up to 24 months
description: Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.
measure: Progression Free Survival (PFS) Assessed by Investigator
time frame: Up to 24 months
description: Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.
measure: Best Overall Response (BOR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer Assessment
time frame: Up to 24 months
description: The Best Overall Response (BOR) with confirmation for a participant is defined as the best confirmed response (Confirmed Complete Response [CR] > Confirmed Partial Response [PR] > Stable Disease [SD] > Progressive Disease [PD] > Not Evaluable [NE]) from first T cell infusion until disease progression or initiation of new anti-cancer therapy, whichever is earlier, as assessed by independent reviewer per RECIST v1.1 criteria.
measure: Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Independent Reviewer
time frame: Up to 24 months
description: Overall response rate (ORR) defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) via independent reviewer assessment per RECIST v1.1 relative to the total number of participants in the analysis population. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters (mm). Confidence intervals (CI) were calculated using the exact (Clopper-Pearson) method.
measure: Time to Response (TTR) Assessed by Independent Reviewer
time frame: Up to 24 months
description: Time to response was defined as the interval of time between the date of T-cell infusion and the first documented evidence of the confirmed response (PR or CR), in the subset of participants with a confirmed PR or CR as their best confirmed overall response. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm.
measure: Duration of Response (DOR) Assessed by Independent Reviewer
time frame: Up to 24 months
description: Duration of response was defined as the interval between the initial date of confirmed response (PR/CR) and the date of progressive disease or death among participants with a confirmed response per RECIST 1.1. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.
measure: Progression Free Survival (PFS) Assessed by Independent Reviewer
time frame: Up to 24 months
description: Progression free survival was defined as the interval between the date of T cell infusion and the earliest date of disease progression or death due to any cause. Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. PFS based on responses assessed by independent reviewer per RECIST v1.1 is presented. Kaplan-Meier Median and 95% confidence intervals are presented. Confidence intervals were calculated using the Brookmeyer-Crowley method.
measure: Number of Participants With Serious Adverse Events (SAEs) and Non-SAEs
time frame: Up to 24 months
description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAE is defined as any untoward medical occurrence that, at any dose can result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth or is medically significant or requires intervention to prevent one or the outcomes listed above.
measure: Number of Participants With Adverse Event of Special Interest (AESI)
time frame: Up to 24 months
description: An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. The AESI included events of Cytokine release syndrome (CRS), Haematopoietic cytopenias (including pancytopenia and aplastic anaemia), Graft versus host disease (GvHD), Immune Effector-Cell Associated Neurotoxicity Syndrome (ICANS), and Guillain-Barre syndrome.
measure: Number of Participants With Any Grade Increase in Hematology Results at Worst-case Post-baseline
time frame: Up to 24 months
description: Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets, leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented.
measure: Number of Participants With Any Grade Increase in Clinical Chemistry Results at Worst-case Post-baseline
time frame: Up to 24 months
description: Blood samples were collected for the analysis clinical chemistry parameters: glucose, albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, creatinine, potassium, magnesium, sodium, phosphate, calcium. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.0, where Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to baseline grade. Data of number of participants with any grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented.
measure: Number of Participants With Replication Competent Lentivirus (RCL)
time frame: Day 1 (pre-infusion), and at Week 12, Week 24, and 1 year post-infusion
description: RCL was monitored using a polymerase chain reaction (PCR)-based assay that detects and measures copies of the gene coding for the vector's envelope protein, namely vesicular stomatitis virus G protein (VSV-G).
measure: Number of Participants With Insertional Oncogenesis
time frame: Up to 2 years
description: Peripheral blood mononuclear cells (PBMC) samples were collected for monitoring insertional oncogenesis by PCR for gene modified cells in the blood. DNA from participant identified with >1% PBMC at >=1 year post T-cell infusion was sent for integration site analysis. Integration site analysis was used to assess the possibility of insertional oncogenesis. Participants with insertional oncogenesis were participants with any clones representing >20% of the total.
measure: Number of Participants With Positive Anti-drug Antibodies (ADAs)
time frame: Up to 24 Months
description: Serum samples were collected to analyze for the presence of ADAs using validated immunoassays.
measure: Maximum Transgene Expansion (Cmax) of GSK3377794
time frame: Day 2 to Day 15
description: Cmax was defined as peak cell expansion during the interventional phase. Blood samples were collected to measure Cmax.
measure: Time to Cmax (Tmax)
time frame: Day 2 to Day 15
description: Tmax was defined as time to peak cell expansion during the interventional phase. Blood samples were collected to measure Tmax.
measure: Area Under the Time Curve From Zero to Time 28 Days AUC(0-28) of GSK3377794
time frame: Up to 28 days
description: Area under the cell expansion-time curve from first T-cell infusion to Day 28. Blood samples were collected to measure AUC (0-28 days).
measure: Change From Baseline in Electrocardiogram (ECG) Parameters- PR Interval, QRS Duration, QT Interval, QTcB Interval, QTcF Interval and RR Interval
time frame: Baseline, Day 1, Day 4 and Day 8
description: Triplicate 12-Lead ECGs were collected at baseline visit and single ECGs at other timepoints. At each time point during the study ECG was taken using an ECG machine that automatically calculates the heart rate and measured the PR interval, QRS duration, QTcB, QTcF intervals, RR interval and uncorrected QT interval. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value.
measure: Change From Baseline in ECG Mean Heart Rate
time frame: Baseline, Day 1 (Pre-dose), Day 4 and Day 8
description: Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline is the most recent, non-missing value within 7 days prior to the lymphodepleting chemotherapy. Change from baseline was to be calculated by subtracting post-dose value from baseline value.
arm group label: letetresgene autoleucel (GSK3377794)
arm group type: Experimental
description: Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive letetresgene autoleucel (GSK3377794), as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy.
intervention type: Drug
intervention name: letetresgene autoleucel (GSK3377794)
description: Letetresgene autoleucel (GSK3377794) as an IV infusion.
arm group label: letetresgene autoleucel (GSK3377794)
intervention type: Drug
intervention name: Cyclophosphamide
description: Cyclophosphamide will be used as a lymphodepleting chemotherapy.
arm group label: letetresgene autoleucel (GSK3377794)
intervention type: Drug
intervention name: Fludarabine
description: Fludarabine will be used as a lymphodepleting chemotherapy.
arm group label: letetresgene autoleucel (GSK3377794)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: United States
responsible party type: Sponsor
mesh term: Liposarcoma
mesh term: Liposarcoma, Myxoid
mesh term: Cyclophosphamide
mesh term: Fludarabine
sharing ipd: Yes
ipd description: IPD for this study will be made available via the Clinical Study Data Request site.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
ipd access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
ipd url: http://clinicalstudydatarequest.com
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