<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/NCT04424641</url>
  </required_header>
  <id_info>
    <org_study_id>GCT1044-01</org_study_id>
    <secondary_id>2019-003998-26</secondary_id>
    <secondary_id>MOH_2020-07-26_008713</secondary_id>
    <nct_id>NCT04424641</nct_id>
  </id_info>
  <brief_title>A Study on the Safety of GEN1044 (DuoBody®-CD3x5T4) in Patients With Malignant Solid Tumors</brief_title>
  <official_title>First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1044 in Subjects With Malignant Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genmab</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Genmab</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose&#xD;
      (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is an open-label, multi-center safety trial of GEN1044. The trial consists of two&#xD;
      parts: a dose-escalation part (Phase 1) and an expansion part (Phase 2a). The expansion part&#xD;
      of the trial will be initiated once the RP2D has been determined from Phase 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was terminated due to MTD was reached&#xD;
  </why_stopped>
  <start_date type="Actual">July 15, 2020</start_date>
  <completion_date type="Actual">October 29, 2021</completion_date>
  <primary_completion_date type="Actual">October 29, 2021</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Dose Limiting Toxicities (DLTs)</measure>
    <time_frame>From Day 1 to Day 21 of first cycle</time_frame>
    <description>The DLT was defined as Grade (G) &gt;= 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome; any G3 or 4 hematologic and non-hematologic toxicity (with exceptions defined by the protocol); laboratory abnormality that required clinically significant medical intervention, led to hospitalization, persisted for &gt;1 week, or resulted in a drug-induced liver injury; G3 or 4 febrile neutropenia; liver toxicity defined by Hy's law; any treatment-related toxicity that caused treatment discontinuation during Cycle 1; or any G5 toxicity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>Day 1 through Day 263 (corresponding to maximum observed duration)</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is 'medically significant']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of GEN1044 and 30 days after the last dose received.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Abnormal Laboratory Values</measure>
    <time_frame>Day 1 through Day 263 (corresponding to maximum observed duration)</time_frame>
    <description>Number of participants with laboratory values of Grade &gt;= 3 by NCI-CTCAE v5.0 are reported. The NCI-CTCAE is a descriptive terminology that is used for gradings (Grade 1-5) of Adverse Events (AEs) and of laboratory values; the latter being summarized here.&#xD;
This table reports laboratory values graded only on the numerical value of the reported parameter and is therefore not graded by symptoms or signs. The abnormal laboratory values assessed by the investigator as being AEs are reported also in the AE table.&#xD;
In case a participant reported multiple severity grades for a laboratory value, only the maximum grade was used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Complete Response (CR) or Partial Response (PR)</measure>
    <time_frame>Day 1 through Day 233</time_frame>
    <description>The radiological evaluation based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) was performed by investigator using computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to &lt; 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of longest diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044</measure>
    <time_frame>Day 1 through Day 263 (predose on Day 1 of Cycles 1, 2, 3, 5, 7, and then on Day 1 of every 4 cycles thereafter, end of treatment [EOT], and 30 days after last study drug)</time_frame>
    <description>The detection and titer characterization of ADAs was performed using validated, specific, and sensitive electrochemiluminescence immunoassay (ECLIA) methods. Number of participants with ADA positive post baseline to GEN1044 are reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Locally Advanced or Metastatic Solid Tumor(s)</condition>
  <condition>Prostate Cancer</condition>
  <condition>Esophageal Cancer</condition>
  <condition>Triple Negative Breast Cancer (TNBC)</condition>
  <condition>Squamous Cell Carcinoma of Head and Neck (SCCHN)</condition>
  <condition>Non-small Cell Lung Cancer (NSCLC)</condition>
  <condition>Bladder Cancer</condition>
  <condition>Uterine Cancer</condition>
  <arm_group>
    <arm_group_label>GEN1044</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4.</intervention_name>
    <description>GEN1044 will be administered intravenously in cycles of 21 days.</description>
    <arm_group_label>GEN1044</arm_group_label>
    <other_name>DuoBody®-CD3x5T4</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
        Dose-escalation part:&#xD;
&#xD;
        • Patient with locally advanced or metastatic solid tumor(s) (excluding patients with&#xD;
        primary central nervous system [CNS] tumors), who has experienced disease progression while&#xD;
        on standard therapy or is intolerant of, or not eligible for, standard therapy.&#xD;
&#xD;
        Expansion part:&#xD;
&#xD;
        • Must have an advanced or metastatic, pathologically confirmed diagnosis of one of the&#xD;
        following tumors: Uterine Cancer, Prostate Cancer, Esophageal Cancer, TNBC, SCCHN, NSCLC&#xD;
        (both adenocarcinoma [ACC] and squamous cell carcinoma [SCC], Bladder Cancer.&#xD;
&#xD;
        Both parts:&#xD;
&#xD;
          -  Must sign an informed consent form (ICF) indicating that he or she understands the&#xD;
             purpose of, and procedures required for the trial, and is willing to participate in&#xD;
             the trial prior to any trial related assessments or procedures.&#xD;
&#xD;
          -  Must have measurable disease according to response assessment criteria relevant to the&#xD;
             tumor type.&#xD;
&#xD;
          -  Must have an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of&#xD;
             0-1 at Screening and on C1D1.&#xD;
&#xD;
          -  A woman of reproductive potential must agree to use adequate contraception during the&#xD;
             trial and for 4 months after the last GEN1044 administration. Adequate contraception&#xD;
             is defined as highly effective methods of contraception.&#xD;
&#xD;
        Key Exclusion Criteria (both parts):&#xD;
&#xD;
          1. Has an uncontrolled intercurrent illness, including but not limited to:&#xD;
&#xD;
               1. Ongoing or active infection requiring intravenous treatment with anti-infective&#xD;
                  therapy&#xD;
&#xD;
               2. Symptomatic congestive heart failure (grade III or IV as classified by the New&#xD;
                  York Heart Association), unstable angina pectoris or cardiac arrhythmia.&#xD;
&#xD;
               3. Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or&#xD;
                  diastolic blood pressure ≥100 mmHg, despite optimal medical management.&#xD;
&#xD;
               4. Ongoing or recent evidence of significant autoimmune disease. Patients with a&#xD;
                  history of grade 3 or higher immune-related adverse events that led to treatment&#xD;
                  discontinuation.&#xD;
&#xD;
               5. Patients with a prior history of myositis, Guillain-Barré syndrome, or myasthenia&#xD;
                  gravis of any grade.&#xD;
&#xD;
               6. History of chronic liver disease or evidence of hepatic cirrhosis.&#xD;
&#xD;
               7. History of non-infectious pneumonitis that has required steroids, or currently&#xD;
                  has pneumonitis.&#xD;
&#xD;
               8. History of organ allograft (except for corneal transplant) or autologous or&#xD;
                  allogeneic bone marrow transplant, or stem cell rescue within 3 months prior to&#xD;
                  the first dose of GEN1044.&#xD;
&#xD;
               9. Serious, non-healing wound, skin ulcer (of any grade), or bone fracture.&#xD;
&#xD;
          2. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, new or&#xD;
             symptomatic brain metastases or stroke.&#xD;
&#xD;
          3. Prior therapy:&#xD;
&#xD;
             Radiotherapy: Radiotherapy within 14 days prior to first GEN1044 administration.&#xD;
             Palliative radiotherapy will be allowed.&#xD;
&#xD;
          4. Treatment with an anti-cancer agent (within 28 days or after at least 5 half-lives of&#xD;
             the drug, whichever is shorter), prior to GEN1044 administration. Toxicities from&#xD;
             previous anti-cancer therapies that have not resolved.&#xD;
&#xD;
          5. Has a history of ≥ grade 2 cytokine release syndrome (CRS) with other CD3-based&#xD;
             bispecifics, or a history of ≥ grade 3 allergic reactions to monoclonal antibody&#xD;
             therapy as well as known or has known allergies, hypersensitivity, or intolerance to&#xD;
             GEN1044 or its excipients.&#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>Roberto Oliveri, MD</last_name>
    <role>Study Director</role>
    <affiliation>Genmab</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tennesse Oncology, PLLC - Nashville</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet (Copenhagen University Hospital)</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chaim Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Israel</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kemper K, Gielen E, Boross P, Houtkamp M, Plantinga TS, de Poot SA, Burm SM, Janmaat ML, Koopman LA, van den Brink EN, Rademaker R, Verzijl D, Engelberts PJ, Satijn D, Sasser AK, Breij EC. Mechanistic and pharmacodynamic studies of DuoBody-CD3x5T4 in preclinical tumor models. Life Sci Alliance. 2022 Sep 8;5(11):e202201481. doi: 10.26508/lsa.202201481. Print 2022 Nov.</citation>
    <PMID>36271507</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>October 16, 2022</results_first_submitted>
  <results_first_submitted_qc>January 5, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 1, 2023</results_first_posted>
  <last_update_submitted>July 24, 2023</last_update_submitted>
  <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
    <mesh_term>Uterine Neoplasms</mesh_term>
    <mesh_term>Squamous Cell Carcinoma of Head and Neck</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Immunoglobulin G</mesh_term>
    <mesh_term>Antibodies, Bispecific</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT04424641/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>December 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT04424641/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 48 participants signed the informed consent form of whom 37 received study drug. The Safety Committee decided to stop enrollment during the dose-escalation part and therefore the expansion part of trial never started. Consequently, results are available for only the dose-escalation part.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GEN1044 Doses 0.3/3/3 mg</title>
          <description>Participants with locally advanced or metastatic non-central nervous system (CNS) solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on Cycle [C] 1 Day (D] 1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by every 3 weeks (Q3W) until the end of treatment.</description>
        </group>
        <group group_id="P2">
          <title>GEN1044 Doses 1/3/10 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="P3">
          <title>GEN1044 Doses 1/3/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="P4">
          <title>GEN1044 Doses 1/5/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="P5">
          <title>GEN1044 Doses 1/10/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="P6">
          <title>GEN1044 Doses 1/5/37.5 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="P7">
          <title>GEN1044 Doses 1/5/45 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="P8">
          <title>GEN1044 Doses 1/3/60 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="7"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.</population>
      <group_list>
        <group group_id="B1">
          <title>GEN1044 Doses 0.3/3/3 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="B2">
          <title>GEN1044 Doses 1/3/10 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="B3">
          <title>GEN1044 Doses 1/3/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="B4">
          <title>GEN1044 Doses 1/5/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="B5">
          <title>GEN1044 Doses 1/10/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="B6">
          <title>GEN1044 Doses 1/5/37.5 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="B7">
          <title>GEN1044 Doses 1/5/45 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="B8">
          <title>GEN1044 Doses 1/3/60 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="B9">
          <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="1"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="7"/>
            <count group_id="B5" value="6"/>
            <count group_id="B6" value="2"/>
            <count group_id="B7" value="4"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="37"/>
          </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="51.0" spread="NA">Standard deviation was not derived as only one participant was evaluated for this arm.</measurement>
                    <measurement group_id="B2" value="61.3" spread="12.89"/>
                    <measurement group_id="B3" value="60.4" spread="11.21"/>
                    <measurement group_id="B4" value="59.3" spread="8.18"/>
                    <measurement group_id="B5" value="62.3" spread="5.79"/>
                    <measurement group_id="B6" value="52.0" spread="8.49"/>
                    <measurement group_id="B7" value="55.8" spread="15.71"/>
                    <measurement group_id="B8" value="54.2" spread="15.29"/>
                    <measurement group_id="B9" value="58.4" spread="10.85"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Dose Limiting Toxicities (DLTs)</title>
        <description>The DLT was defined as Grade (G) &gt;= 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome; any G3 or 4 hematologic and non-hematologic toxicity (with exceptions defined by the protocol); laboratory abnormality that required clinically significant medical intervention, led to hospitalization, persisted for &gt;1 week, or resulted in a drug-induced liver injury; G3 or 4 febrile neutropenia; liver toxicity defined by Hy's law; any treatment-related toxicity that caused treatment discontinuation during Cycle 1; or any G5 toxicity.</description>
        <time_frame>From Day 1 to Day 21 of first cycle</time_frame>
        <population>Dose-determining set (DDS) included all participants who received at least 1 dose of study drug during the dose-escalation part, and who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 21 days of dosing.</population>
        <group_list>
          <group group_id="O1">
            <title>GEN1044 Doses 0.3/3/3 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O2">
            <title>GEN1044 Doses 1/3/10 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O3">
            <title>GEN1044 Doses 1/3/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O4">
            <title>GEN1044 Doses 1/5/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O5">
            <title>GEN1044 Doses 1/10/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O6">
            <title>GEN1044 Doses 1/5/37.5 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O7">
            <title>GEN1044 Doses 1/5/45 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O8">
            <title>GEN1044 Doses 1/3/60 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Dose Limiting Toxicities (DLTs)</title>
          <description>The DLT was defined as Grade (G) &gt;= 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome; any G3 or 4 hematologic and non-hematologic toxicity (with exceptions defined by the protocol); laboratory abnormality that required clinically significant medical intervention, led to hospitalization, persisted for &gt;1 week, or resulted in a drug-induced liver injury; G3 or 4 febrile neutropenia; liver toxicity defined by Hy's law; any treatment-related toxicity that caused treatment discontinuation during Cycle 1; or any G5 toxicity.</description>
          <population>Dose-determining set (DDS) included all participants who received at least 1 dose of study drug during the dose-escalation part, and who met the minimum exposure criterion and had sufficient safety evaluations or experienced a DLT during the first 21 days of dosing.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="3"/>
                <count group_id="O8" value="4"/>
              </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 group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)</title>
        <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is 'medically significant']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of GEN1044 and 30 days after the last dose received.</description>
        <time_frame>Day 1 through Day 263 (corresponding to maximum observed duration)</time_frame>
        <population>Safety set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>GEN1044 Doses 0.3/3/3 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O2">
            <title>GEN1044 Doses 1/3/10 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O3">
            <title>GEN1044 Doses 1/3/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O4">
            <title>GEN1044 Doses 1/5/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O5">
            <title>GEN1044 Doses 1/10/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O6">
            <title>GEN1044 Doses 1/5/37.5 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O7">
            <title>GEN1044 Doses 1/5/45 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O8">
            <title>GEN1044 Doses 1/3/60 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)</title>
          <description>An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is 'medically significant']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of GEN1044 and 30 days after the last dose received.</description>
          <population>Safety set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="4"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any TESAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Abnormal Laboratory Values</title>
        <description>Number of participants with laboratory values of Grade &gt;= 3 by NCI-CTCAE v5.0 are reported. The NCI-CTCAE is a descriptive terminology that is used for gradings (Grade 1-5) of Adverse Events (AEs) and of laboratory values; the latter being summarized here.&#xD;
This table reports laboratory values graded only on the numerical value of the reported parameter and is therefore not graded by symptoms or signs. The abnormal laboratory values assessed by the investigator as being AEs are reported also in the AE table.&#xD;
In case a participant reported multiple severity grades for a laboratory value, only the maximum grade was used.</description>
        <time_frame>Day 1 through Day 263 (corresponding to maximum observed duration)</time_frame>
        <population>Safety set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>GEN1044 Doses 0.3/3/3 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O2">
            <title>GEN1044 Doses 1/3/10 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O3">
            <title>GEN1044 Doses 1/3/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O4">
            <title>GEN1044 Doses 1/5/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O5">
            <title>GEN1044 Doses 1/10/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O6">
            <title>GEN1044 Doses 1/5/37.5 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O7">
            <title>GEN1044 Doses 1/5/45 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O8">
            <title>GEN1044 Doses 1/3/60 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Laboratory Values</title>
          <description>Number of participants with laboratory values of Grade &gt;= 3 by NCI-CTCAE v5.0 are reported. The NCI-CTCAE is a descriptive terminology that is used for gradings (Grade 1-5) of Adverse Events (AEs) and of laboratory values; the latter being summarized here.&#xD;
This table reports laboratory values graded only on the numerical value of the reported parameter and is therefore not graded by symptoms or signs. The abnormal laboratory values assessed by the investigator as being AEs are reported also in the AE table.&#xD;
In case a participant reported multiple severity grades for a laboratory value, only the maximum grade was used.</description>
          <population>Safety set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lymphocyte count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serum amylase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypomagnesemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypokalemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoalbuminemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood bilirubin increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma-glutamyl transferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypermagnesemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Complete Response (CR) or Partial Response (PR)</title>
        <description>The radiological evaluation based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) was performed by investigator using computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to &lt; 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of longest diameters.</description>
        <time_frame>Day 1 through Day 233</time_frame>
        <population>Full analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>GEN1044 Doses 0.3/3/3 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O2">
            <title>GEN1044 Doses 1/3/10 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O3">
            <title>GEN1044 Doses 1/3/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O4">
            <title>GEN1044 Doses 1/5/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O5">
            <title>GEN1044 Doses 1/10/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O6">
            <title>GEN1044 Doses 1/5/37.5 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O7">
            <title>GEN1044 Doses 1/5/45 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O8">
            <title>GEN1044 Doses 1/3/60 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complete Response (CR) or Partial Response (PR)</title>
          <description>The radiological evaluation based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) was performed by investigator using computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to &lt; 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of longest diameters.</description>
          <population>Full analysis set included all participants who received at least 1 dose of study drug. Participants were classified according to the assigned dose level cohort.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044</title>
        <description>The detection and titer characterization of ADAs was performed using validated, specific, and sensitive electrochemiluminescence immunoassay (ECLIA) methods. Number of participants with ADA positive post baseline to GEN1044 are reported.</description>
        <time_frame>Day 1 through Day 263 (predose on Day 1 of Cycles 1, 2, 3, 5, 7, and then on Day 1 of every 4 cycles thereafter, end of treatment [EOT], and 30 days after last study drug)</time_frame>
        <population>Immunogenicity analysis set included all participants who received at least 1 dose of study drug and had evaluable immunogenicity samples.</population>
        <group_list>
          <group group_id="O1">
            <title>GEN1044 Doses 0.3/3/3 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O2">
            <title>GEN1044 Doses 1/3/10 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O3">
            <title>GEN1044 Doses 1/3/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O4">
            <title>GEN1044 Doses 1/5/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O5">
            <title>GEN1044 Doses 1/10/30 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O6">
            <title>GEN1044 Doses 1/5/37.5 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O7">
            <title>GEN1044 Doses 1/5/45 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
          <group group_id="O8">
            <title>GEN1044 Doses 1/3/60 mg</title>
            <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044</title>
          <description>The detection and titer characterization of ADAs was performed using validated, specific, and sensitive electrochemiluminescence immunoassay (ECLIA) methods. Number of participants with ADA positive post baseline to GEN1044 are reported.</description>
          <population>Immunogenicity analysis set included all participants who received at least 1 dose of study drug and had evaluable immunogenicity samples.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="4"/>
                <count group_id="O8" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>For AEs: Day 1 through Day 263 (corresponding to maximum observed duration); For All-cause mortality: From date of inform consent form through Day 263 (corresponding to maximum observed duration)</time_frame>
      <desc>The adverse events were evaluated per the safety set. The safety set included all participants who received at least 1 dose of GEN1044. Participants were classified according to the assigned dose level cohort. One (1) death in the 1/10/30 mg reporting group was recorded 5 days after the patient withdrew trial consent.</desc>
      <group_list>
        <group group_id="E1">
          <title>GEN1044 Doses 0.3/3/3 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (0.3 mg on C1D1 and 3 mg on C1D8 and C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="E2">
          <title>GEN1044 Doses 1/3/10 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 10 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="E3">
          <title>GEN1044 Doses 1/3/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="E4">
          <title>GEN1044 Doses 1/5/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="E5">
          <title>GEN1044 Doses 1/10/30 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 10 mg on C1D8, and 30 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="E6">
          <title>GEN1044 Doses 1/5/37.5 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 37.5 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="E7">
          <title>GEN1044 Doses 1/5/45 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 5 mg on C1D8, and 45 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
        <group group_id="E8">
          <title>GEN1044 Doses 1/3/60 mg</title>
          <description>Participants with locally advanced or metastatic non-CNS solid tumor(s) received an IV infusion of GEN1044 weekly (1 mg on C1D1, 3 mg on C1D8, and 60 mg on C1D15) for the first 4 cycles (each cycle was 21 days), followed by Q3W until the end of treatment.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (v24.1)</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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Atrial Flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="6" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="6" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="4" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="10" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="13" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="9" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="9" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E8" events="9" subjects_affected="3" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </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="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour Associated Fever</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="5" subjects_affected="2" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Exfoliative Generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (v24.1)</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="1" subjects_at_risk="1"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="6"/>
              </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="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E3" events="23" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E4" events="15" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E5" events="13" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="15" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E8" events="12" subjects_affected="4" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E3" events="9" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E4" events="6" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E5" events="6" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="6" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E8" events="10" subjects_affected="5" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="8" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E3" events="10" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="11" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="8" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E8" events="8" subjects_affected="4" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="3" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E3" events="8" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="7" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Non-cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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="4" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="10" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E3" events="6" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="14" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E6" events="4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E7" events="4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E8" events="14" subjects_affected="4" subjects_at_risk="6"/>
              </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="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Clostridium Difficile Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nail Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion Related Reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Amylase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood Creatine Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>C-reactive Protein Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT Prolonged</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>International Normalised Ratio Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lipase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="6"/>
              </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="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="3" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="2" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Bone Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="5" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </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="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="6" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E8" events="5" subjects_affected="2" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Exfoliative Generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nail Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Palmar-plantar Erythrodysaesthesia Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Prurigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash Maculo-papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="4" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Rash Pruritic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hot Flush</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 12 months but less than 18 months from the end of study (database lock). The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Upon review and evaluation of the overall safety profile and safety signals of GEN1044 during the dose-escalation part, the Safety Committee decided to stop further enrollment and the Sponsor decided to stop the compound development. Hence, the expansion part of the trial was never initiated, and while a majority of the pharmacokinetic (PK) samples from the dose-escalation part were quantified, the PK parameters were not calculated due to termination of the trial.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Information</name_or_title>
      <organization>Genmab</organization>
      <phone>+45 7020 2728</phone>
      <email>clinicaltrials@genmab.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/NCT04424641
org study id: GCT1044-01
secondary id: 2019-003998-26
secondary id: MOH_2020-07-26_008713
nct id: NCT04424641
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the trial is to evaluate the safety, determine the recommended Phase 2 dose
      (RP2D), and assess preliminary clinical activity of GEN1044 in patients with solid tumors.
The trial is an open-label, multi-center safety trial of GEN1044. The trial consists of two
      parts: a dose-escalation part (Phase 1) and an expansion part (Phase 2a). The expansion part
      of the trial will be initiated once the RP2D has been determined from Phase 1.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Dose Limiting Toxicities (DLTs)
time frame: From Day 1 to Day 21 of first cycle
description: The DLT was defined as Grade (G) >= 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome; any G3 or 4 hematologic and non-hematologic toxicity (with exceptions defined by the protocol); laboratory abnormality that required clinically significant medical intervention, led to hospitalization, persisted for >1 week, or resulted in a drug-induced liver injury; G3 or 4 febrile neutropenia; liver toxicity defined by Hy's law; any treatment-related toxicity that caused treatment discontinuation during Cycle 1; or any G5 toxicity.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
time frame: Day 1 through Day 263 (corresponding to maximum observed duration)
description: An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above [medical and scientific judgment must be exercised in deciding whether an AE is 'medically significant']); required inpatient hospitalization or prolongation of existing hospitalization. A TEAE is defined as an AE occurring or worsening between the first dose of GEN1044 and 30 days after the last dose received.
measure: Number of Participants With Abnormal Laboratory Values
time frame: Day 1 through Day 263 (corresponding to maximum observed duration)
description: Number of participants with laboratory values of Grade >= 3 by NCI-CTCAE v5.0 are reported. The NCI-CTCAE is a descriptive terminology that is used for gradings (Grade 1-5) of Adverse Events (AEs) and of laboratory values; the latter being summarized here.
This table reports laboratory values graded only on the numerical value of the reported parameter and is therefore not graded by symptoms or signs. The abnormal laboratory values assessed by the investigator as being AEs are reported also in the AE table.
In case a participant reported multiple severity grades for a laboratory value, only the maximum grade was used.
measure: Number of Participants With Complete Response (CR) or Partial Response (PR)
time frame: Day 1 through Day 233
description: The radiological evaluation based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) was performed by investigator using computed tomography (CT) scan/ magnetic resonance imaging (MRI) scan/ positron emission tomography (PET) scan. The CR was defined as disappearance of all target and non-target lesions and all pathological lymph nodes must have decreased to < 10 mm in short axis. The PR was defined as at least a 30% decrease in the sum of the longest diameters of target lesions taking as reference the baseline sum of longest diameters.
measure: Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1044
time frame: Day 1 through Day 263 (predose on Day 1 of Cycles 1, 2, 3, 5, 7, and then on Day 1 of every 4 cycles thereafter, end of treatment [EOT], and 30 days after last study drug)
description: The detection and titer characterization of ADAs was performed using validated, specific, and sensitive electrochemiluminescence immunoassay (ECLIA) methods. Number of participants with ADA positive post baseline to GEN1044 are reported.
arm group label: GEN1044
arm group type: Experimental
intervention type: Biological
intervention name: GEN1044 is an immunoglobulin G1 (IgG1) bispecific antibody targeting CD3 and 5T4.
description: GEN1044 will be administered intravenously in cycles of 21 days.
arm group label: GEN1044
other name: DuoBody®-CD3x5T4
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roberto Oliveri, MD
role: Study Director
affiliation: Genmab
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
country: Israel
country: Spain
country: United States
citation: Kemper K, Gielen E, Boross P, Houtkamp M, Plantinga TS, de Poot SA, Burm SM, Janmaat ML, Koopman LA, van den Brink EN, Rademaker R, Verzijl D, Engelberts PJ, Satijn D, Sasser AK, Breij EC. Mechanistic and pharmacodynamic studies of DuoBody-CD3x5T4 in preclinical tumor models. Life Sci Alliance. 2022 Sep 8;5(11):e202201481. doi: 10.26508/lsa.202201481. Print 2022 Nov.
PMID: 36271507
responsible party type: Sponsor
mesh term: Triple Negative Breast Neoplasms
mesh term: Uterine Neoplasms
mesh term: Squamous Cell Carcinoma of Head and Neck
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Immunoglobulins, Intravenous
mesh term: Immunoglobulin G
mesh term: Antibodies, Bispecific
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Upon review and evaluation of the overall safety profile and safety signals of GEN1044 during the dose-escalation part, the Safety Committee decided to stop further enrollment and the Sponsor decided to stop the compound development. Hence, the expansion part of the trial was never initiated, and while a majority of the pharmacokinetic (PK) samples from the dose-escalation part were quantified, the PK parameters were not calculated due to termination of the trial.
point of contact: 