<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/NCT03251924</url>
  </required_header>
  <id_info>
    <org_study_id>CA021-002</org_study_id>
    <secondary_id>2017-000238-73</secondary_id>
    <nct_id>NCT03251924</nct_id>
  </id_info>
  <brief_title>A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1/2 Dose Escalation and Combination Cohort Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Efficacy of BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate BMS-986226 administered alone or in combination&#xD;
      with nivolumab or ipilimumab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study CA021-002 was terminated because the Sponsor discontinued further development of&#xD;
    BMS-986226 due to a change in business objectives. The decision for the study closure was not&#xD;
    related to any safety concerns associated with BMS-986226.&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">December 20, 2021</completion_date>
  <primary_completion_date type="Actual">December 20, 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>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Participants Experiencing Adverse Events (AEs)</measure>
    <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants Experiencing Serious Adverse Events (SAEs)</measure>
    <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
    <description>Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants Experiencing Adverse Events (AEs) Meeting Dose Limiting Toxicity (DLT) Criteria</measure>
    <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Dose limiting toxicity (DLT) is defined based on the incidence, intensity, and duration of AEs for which no clear alternative cause is identified. The DLT period will be 28 days (4 weeks) in the Preliminary Safety Cohorts. Any toxicities that occur beyond the 4-week DLT period will also be considered in dose-level decisions. For the purpose of participant management, any AE that meets DLT criteria, regardless of the cycle in which it occurs, will lead to discontinuation of study treatment. AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants Experiencing Adverse Events Leading to Discontinuation</measure>
    <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants Experiencing Adverse Events Resulting in Death</measure>
    <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants Experiencing Clinical Laboratory Abnormalities</measure>
    <time_frame>From first dose up to 30 days post last dose (approximately 28 months)</time_frame>
    <description>The number of participants experiencing abnormal laboratory results of Grade 3 or higher. Laboratory values will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 with Grade 3=severe and Grade 4=life threatening.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>From first dose up to documented disease progression, up to 48 months</time_frame>
    <description>ORR is defined as the percentage of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) as assessed by investigator per RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR for a participant is defined as the best response designation recorded between the date of first dose (or date of randomization) and the date of first objectively documented progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Duration of Response (DOR)</measure>
    <time_frame>From first dose up to the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 24 months)</time_frame>
    <description>DOR for a participant with confirmed response is defined as the time from the date of first response CR or PR to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed will be censored on the date of their last tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) Rate at 24 Weeks</measure>
    <time_frame>At 24 weeks</time_frame>
    <description>The PFSR is defined as the Kaplan Meier estimate of percentage of treated participants remaining progression free and surviving at the prespecified timepoint of 24 weeks since the first dosing date. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considered progression.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-Drug Antibodies (ADA) for BMS-986226</measure>
    <time_frame>Predose on cycles 1-6, post dose on C1D15, and 30, 60, and 100 days post last dose (up to approximately 31 months)</time_frame>
    <description>ADA for BMS-986226 is defined as the number of participants found to have seroconverted or boosted their pre-existing ADA during the study period. Baseline ADA positive is defined as ADA is detected in the last sample before initiation of treatment. ADA positive is defined as 1) an ADA detected (positive seroconversion) sample in a participant for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline in Cell Surface ICOS Expression on T Cells</measure>
    <time_frame>From baseline up to pre-dose and 4 hours post dose on C1D1 and pre-dose and 4 hours post dose on C2D1 (approximately 31 months)</time_frame>
    <description>Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in cell surface Inducible Costimulator (ICOS) expression on T cells. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes in MFI by flow cytometry. An increase in MFI between patient samples corresponds to an increase in cell surface ICOS expression on target cell subsets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes From Baseline in ICOS Ligand+ B Cells</measure>
    <time_frame>From baseline up to pre-dose and 4 hours post dose on C1D1, 72 hours post dose on C1D4, and pre-dose on C2D1 (approximately 31 months)</time_frame>
    <description>Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in ICOS ligand+ B cells in the tumor and peripheral blood. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes in MFI by flow cytometry. An increase in MFI between patient samples corresponds to an increase in cell surface ICOS expression on target cell subsets.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
    <description>Cmax is the maximum serum concentration that a drug achieves after the drug has been administered and before the administration of a second dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effective Elimination Half-Life (T-HALFeff)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C2D1 and C3D1 (approximately 31 months)</time_frame>
    <description>Effective elimination half-life that explains the degree of accumulation observed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Observed Serum Concentrations (Ctrough)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. Pre-dose on C5D1 and C6D1. Pre-dose and 0.5 hours post dose on C7D1. (approximately 31 months)</time_frame>
    <description>Trough observed serum concentrations (Ctrough) is defined as the concentration reached by a drug immediately before the next dose is administered</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Maximum Observed Serum Concentration (Tmax)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
    <description>Tmax is defined as the amount of time that a drug is present at the maximum concentration in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration [AUC (0-T)]</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
    <description>AUC(0-t) (partial AUC) is defined as the area under the concentration-time curve from dosing (time 0) to time t. AUC(0-t) may be computed for one or more values of t, with specific values of t determined after observing the data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Concentration-Time Curve in 1 Dosing Interval [AUC (TAU)]</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
    <description>AUC (TAU) is defined as the area under the plasma concentration-time curve from time zero to the end of the dosing interval</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Body Clearance (CLT)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
    <description>CLT is defined as the elimination of the drug from the body</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Concentration Over a Dosing Interval (Css-avg)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
    <description>Css-avg is defined as the average concentration over a dosing interval (AUC[TAU]/tau)&#xD;
Note: Coefficient of variation is reported in lieu of geometric coefficient of variation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Index - Area Under Curve (AI-AUC)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
    <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose. The area under curve is defined as the area under the plot of plasma concentration of a drug versus time after dosage which reflects the extent of exposure to a drug and its clearance rate from the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Index - Cmax (AI-Cmax)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. (Approximately 31 months)</time_frame>
    <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose. Cmax is the maximum serum concentration that a drug achieves after the drug has been administered and before the administration of a second dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Index - Concentrations at the End of Dosing Interval (AI-CTAU)</measure>
    <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. (Approximately 31 months)</time_frame>
    <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Cancer</condition>
  <condition>Tumors</condition>
  <condition>Neoplasm</condition>
  <condition>Malignancy</condition>
  <arm_group>
    <arm_group_label>BMS-986226</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMS-986226 and Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMS-986226 and Ipilimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>administered intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986226</intervention_name>
    <description>specified dose on specified days</description>
    <arm_group_label>BMS-986226</arm_group_label>
    <arm_group_label>BMS-986226 and Ipilimumab</arm_group_label>
    <arm_group_label>BMS-986226 and Nivolumab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>specified dose on specified days</description>
    <arm_group_label>BMS-986226 and Nivolumab</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>PD-1 receptor blocking monoclonal antibody [mAb]</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>specified dose on specified days</description>
    <arm_group_label>BMS-986226 and Ipilimumab</arm_group_label>
    <other_name>BMS-734016</other_name>
    <other_name>MDX010</other_name>
    <other_name>Checkpoint blocking antibody that recognizes CTLA-4</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Tetanus Vaccine</intervention_name>
    <description>specified dose on specified days</description>
    <arm_group_label>BMS-986226</arm_group_label>
    <arm_group_label>BMS-986226 and Ipilimumab</arm_group_label>
    <arm_group_label>BMS-986226 and Nivolumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please&#xD;
        visit www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced solid tumors&#xD;
&#xD;
          -  Histological or cytological confirmation of a malignancy that is advanced (metastatic&#xD;
             and/or unresectable) with measureable disease as defined by Response Evaluation&#xD;
             Criteria In Solid Tumors (RECIST) v1.1 or PCWG3 (prostate only).&#xD;
&#xD;
          -  At least 1 lesion accessible for biopsy in addition to the target lesion&#xD;
&#xD;
          -  Participants must have received, and then progressed or been intolerant to, at least 1&#xD;
             standard treatment regimen&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with active central nervous system (CNS) metastases, untreated CNS&#xD;
             metastases, or with the CNS as the only site of disease are excluded (controlled brain&#xD;
             metastases will be allowed to enroll)&#xD;
&#xD;
          -  Participants with carcinomatous meningitis&#xD;
&#xD;
          -  Prior malignancy active within the previous 2 years except for locally curable cancers&#xD;
             that have been apparently cured, such as basal or squamous cell skin cancer,&#xD;
             superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast&#xD;
&#xD;
          -  Active, known, or suspected autoimmune disease&#xD;
&#xD;
          -  Uncontrolled or significant cardiovascular disease&#xD;
&#xD;
          -  Participants with known allergies to egg products, neomycin and tetanus toxoid.&#xD;
&#xD;
          -  Prior adverse reaction to tetanus toxoid- containing vaccines.&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution - 0005</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0004</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0014</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0006</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0003</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0007</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>Zuerich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.BMSStudyConnect.com</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <results_first_submitted>December 16, 2022</results_first_submitted>
  <results_first_submitted_qc>January 31, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 28, 2023</results_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 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>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Blocking</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/24/NCT03251924/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>No participants were treated with BMS-986226 in combination with nivolumab (Parts B1 and B2) and no participants were treated in Parts D and E</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Preliminary - BMS-986226 2 mg</title>
          <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
        </group>
        <group group_id="P2">
          <title>Preliminary - BMS-986226 8 mg</title>
          <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
        </group>
        <group group_id="P3">
          <title>Part A - BMS-986226 25 mg</title>
          <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="P4">
          <title>Part A - BMS-986226 80 mg</title>
          <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="P5">
          <title>Part A - BMS-986226 200 mg</title>
          <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="P6">
          <title>Part A - BMS-986226 400 mg</title>
          <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="P7">
          <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
        <group group_id="P8">
          <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
        <group group_id="P9">
          <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="12"/>
                <participants group_id="P9" count="9"/>
              </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="3"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="11"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="9"/>
                <participants group_id="P7" count="7"/>
                <participants group_id="P8" count="11"/>
                <participants group_id="P9" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="8"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="6"/>
                <participants group_id="P8" count="10"/>
                <participants group_id="P9" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event unrelated to study drug</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="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Toxicity</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="1"/>
                <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 group_id="P9" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reasons</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 group_id="P9" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to discontinue study treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Preliminary - BMS-986226 2 mg</title>
          <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
        </group>
        <group group_id="B2">
          <title>Preliminary - BMS-986226 8 mg</title>
          <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
        </group>
        <group group_id="B3">
          <title>Part A - BMS-986226 25 mg</title>
          <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="B4">
          <title>Part A - BMS-986226 80 mg</title>
          <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="B5">
          <title>Part A - BMS-986226 200 mg</title>
          <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="B6">
          <title>Part A - BMS-986226 400 mg</title>
          <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="B7">
          <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
        <group group_id="B8">
          <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
        <group group_id="B9">
          <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
        <group group_id="B10">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="11"/>
            <count group_id="B5" value="9"/>
            <count group_id="B6" value="9"/>
            <count group_id="B7" value="10"/>
            <count group_id="B8" value="12"/>
            <count group_id="B9" value="9"/>
            <count group_id="B10" value="80"/>
          </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="59.3" spread="10.4"/>
                    <measurement group_id="B2" value="58.3" spread="7.8"/>
                    <measurement group_id="B3" value="63.6" spread="12.3"/>
                    <measurement group_id="B4" value="62.5" spread="9.7"/>
                    <measurement group_id="B5" value="55.3" spread="15.9"/>
                    <measurement group_id="B6" value="61.7" spread="16.9"/>
                    <measurement group_id="B7" value="55.7" spread="9.6"/>
                    <measurement group_id="B8" value="62.3" spread="11.7"/>
                    <measurement group_id="B9" value="58.3" spread="7.1"/>
                    <measurement group_id="B10" value="59.7" spread="11.5"/>
                  </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="5"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="7"/>
                    <measurement group_id="B9" value="7"/>
                    <measurement group_id="B10" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="8"/>
                    <measurement group_id="B9" value="5"/>
                    <measurement group_id="B10" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="30"/>
                  </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 group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="1"/>
                  </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 group_id="B10" 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="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="12"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="69"/>
                  </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 group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Experiencing Adverse Events (AEs)</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Adverse Events (AEs)</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants</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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="9"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="12"/>
                    <measurement group_id="O9" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Experiencing Serious Adverse Events (SAEs)</title>
        <description>Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.</description>
        <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Serious Adverse Events (SAEs)</title>
          <description>Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.</description>
          <population>All treated participants</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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="9"/>
                    <measurement group_id="O7" value="5"/>
                    <measurement group_id="O8" value="9"/>
                    <measurement group_id="O9" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Experiencing Adverse Events (AEs) Meeting Dose Limiting Toxicity (DLT) Criteria</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Dose limiting toxicity (DLT) is defined based on the incidence, intensity, and duration of AEs for which no clear alternative cause is identified. The DLT period will be 28 days (4 weeks) in the Preliminary Safety Cohorts. Any toxicities that occur beyond the 4-week DLT period will also be considered in dose-level decisions. For the purpose of participant management, any AE that meets DLT criteria, regardless of the cycle in which it occurs, will lead to discontinuation of study treatment. AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.</description>
        <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Adverse Events (AEs) Meeting Dose Limiting Toxicity (DLT) Criteria</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Dose limiting toxicity (DLT) is defined based on the incidence, intensity, and duration of AEs for which no clear alternative cause is identified. The DLT period will be 28 days (4 weeks) in the Preliminary Safety Cohorts. Any toxicities that occur beyond the 4-week DLT period will also be considered in dose-level decisions. For the purpose of participant management, any AE that meets DLT criteria, regardless of the cycle in which it occurs, will lead to discontinuation of study treatment. AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.</description>
          <population>All treated participants</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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="9"/>
              </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="1"/>
                    <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 group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Experiencing Adverse Events Leading to Discontinuation</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Adverse Events Leading to Discontinuation</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants</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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="9"/>
              </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="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Experiencing Adverse Events Resulting in Death</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose up to 100 days post last dose, up to approximately 31 months</time_frame>
        <population>All treated paricipants</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Adverse Events Resulting in Death</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated paricipants</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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="7"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="8"/>
                    <measurement group_id="O9" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Experiencing Clinical Laboratory Abnormalities</title>
        <description>The number of participants experiencing abnormal laboratory results of Grade 3 or higher. Laboratory values will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 with Grade 3=severe and Grade 4=life threatening.</description>
        <time_frame>From first dose up to 30 days post last dose (approximately 28 months)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Experiencing Clinical Laboratory Abnormalities</title>
          <description>The number of participants experiencing abnormal laboratory results of Grade 3 or higher. Laboratory values will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 with Grade 3=severe and Grade 4=life threatening.</description>
          <population>All treated participants</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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HEMOGLOBIN</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="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LYMPHOCYTES (ABSOLUTE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LYMPHOCYTES (RELATIVE)</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="1"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALKALINE PHOSPHATASE</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="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="3"/>
                    <measurement group_id="O8" value="2"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASPARTATE AMINOTRANSFERASE</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="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALANINE AMINOTRANSFERASE</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="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-GLUTAMYL TRANSFERASE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BILIRUBIN, TOTAL</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="2"/>
                    <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 group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PHOSPHATE</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="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LIPASE, TOTAL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HYPONATREMIA</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="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HYPERKALEMIA</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="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HYPERGLYCEMIA</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 group_id="O9" value="0"/>
                  </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="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="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR is defined as the percentage of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) as assessed by investigator per RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR for a participant is defined as the best response designation recorded between the date of first dose (or date of randomization) and the date of first objectively documented progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first.</description>
        <time_frame>From first dose up to documented disease progression, up to 48 months</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>ORR is defined as the percentage of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) as assessed by investigator per RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR for a participant is defined as the best response designation recorded between the date of first dose (or date of randomization) and the date of first objectively documented progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first.</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0.0" upper_limit="45.9"/>
                    <measurement group_id="O2" value="0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O4" value="0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O5" value="0" lower_limit="0.0" upper_limit="33.6"/>
                    <measurement group_id="O6" value="0" lower_limit="0.0" upper_limit="33.6"/>
                    <measurement group_id="O7" value="0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O8" value="8.3" lower_limit="0.2" upper_limit="38.5"/>
                    <measurement group_id="O9" value="0" lower_limit="0.0" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Duration of Response (DOR)</title>
        <description>DOR for a participant with confirmed response is defined as the time from the date of first response CR or PR to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed will be censored on the date of their last tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>From first dose up to the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 24 months)</time_frame>
        <population>All treated participants with complete response (CR) or partial response (PR)</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Median Duration of Response (DOR)</title>
          <description>DOR for a participant with confirmed response is defined as the time from the date of first response CR or PR to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed will be censored on the date of their last tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.</description>
          <population>All treated participants with complete response (CR) or partial response (PR)</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="1"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="NA" lower_limit="23.4" upper_limit="23.4">Median not calculable because data were only collected for 1 participant.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) Rate at 24 Weeks</title>
        <description>The PFSR is defined as the Kaplan Meier estimate of percentage of treated participants remaining progression free and surviving at the prespecified timepoint of 24 weeks since the first dosing date. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considered progression.)</description>
        <time_frame>At 24 weeks</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) Rate at 24 Weeks</title>
          <description>The PFSR is defined as the Kaplan Meier estimate of percentage of treated participants remaining progression free and surviving at the prespecified timepoint of 24 weeks since the first dosing date. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considered progression.)</description>
          <population>All treated participants</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="12"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="0.8" upper_limit="51.7"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O4" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O6" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O7" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O8" value="8.3" lower_limit="0.5" upper_limit="31.1"/>
                    <measurement group_id="O9" value="18.8" lower_limit="1.1" upper_limit="53.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-Drug Antibodies (ADA) for BMS-986226</title>
        <description>ADA for BMS-986226 is defined as the number of participants found to have seroconverted or boosted their pre-existing ADA during the study period. Baseline ADA positive is defined as ADA is detected in the last sample before initiation of treatment. ADA positive is defined as 1) an ADA detected (positive seroconversion) sample in a participant for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.</description>
        <time_frame>Predose on cycles 1-6, post dose on C1D15, and 30, 60, and 100 days post last dose (up to approximately 31 months)</time_frame>
        <population>All treated participants with baseline and at lease one post-baseline assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-Drug Antibodies (ADA) for BMS-986226</title>
          <description>ADA for BMS-986226 is defined as the number of participants found to have seroconverted or boosted their pre-existing ADA during the study period. Baseline ADA positive is defined as ADA is detected in the last sample before initiation of treatment. ADA positive is defined as 1) an ADA detected (positive seroconversion) sample in a participant for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.</description>
          <population>All treated participants with baseline and at lease one post-baseline assessment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="11"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline ADA Positive</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="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA Positive after initiation of treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="9"/>
                    <measurement group_id="O9" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline in Cell Surface ICOS Expression on T Cells</title>
        <description>Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in cell surface Inducible Costimulator (ICOS) expression on T cells. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes in MFI by flow cytometry. An increase in MFI between patient samples corresponds to an increase in cell surface ICOS expression on target cell subsets.</description>
        <time_frame>From baseline up to pre-dose and 4 hours post dose on C1D1 and pre-dose and 4 hours post dose on C2D1 (approximately 31 months)</time_frame>
        <population>Biomarker Evaluable Participants: All treated participants with available biomarker data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline in Cell Surface ICOS Expression on T Cells</title>
          <description>Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in cell surface Inducible Costimulator (ICOS) expression on T cells. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes in MFI by flow cytometry. An increase in MFI between patient samples corresponds to an increase in cell surface ICOS expression on target cell subsets.</description>
          <population>Biomarker Evaluable Participants: All treated participants with available biomarker data</population>
          <units>Median of Fluorescence of ICOS (MFI)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="10"/>
                <count group_id="O9" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="9"/>
                    <count group_id="O8" value="10"/>
                    <count group_id="O9" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="985.5" lower_limit="554" upper_limit="1243"/>
                    <measurement group_id="O2" value="659.0" lower_limit="455" upper_limit="775"/>
                    <measurement group_id="O3" value="878.0" lower_limit="599" upper_limit="1361"/>
                    <measurement group_id="O4" value="482" lower_limit="197" upper_limit="912"/>
                    <measurement group_id="O5" value="434.0" lower_limit="169" upper_limit="884"/>
                    <measurement group_id="O6" value="634.0" lower_limit="94" upper_limit="1166"/>
                    <measurement group_id="O7" value="592.0" lower_limit="162" upper_limit="933"/>
                    <measurement group_id="O8" value="714.0" lower_limit="234" upper_limit="1438"/>
                    <measurement group_id="O9" value="506.5" lower_limit="20" upper_limit="943"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C1D1- Pre-Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-394.0" lower_limit="-394" upper_limit="394"/>
                    <measurement group_id="O6" value="-636.0" lower_limit="-636" upper_limit="-636"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C1D1- 4 hours post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="7"/>
                    <count group_id="O7" value="2"/>
                    <count group_id="O8" value="10"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1049.0" lower_limit="-1049" upper_limit="-1049"/>
                    <measurement group_id="O2" value="-603.0" lower_limit="-603" upper_limit="-603"/>
                    <measurement group_id="O3" value="-762.0" lower_limit="-847" upper_limit="-565"/>
                    <measurement group_id="O4" value="-391.0" lower_limit="-635" upper_limit="-176"/>
                    <measurement group_id="O5" value="-324.0" lower_limit="-481" upper_limit="-95"/>
                    <measurement group_id="O6" value="-545.0" lower_limit="-1029" upper_limit="-184"/>
                    <measurement group_id="O7" value="-382.5" lower_limit="-649" upper_limit="-116"/>
                    <measurement group_id="O8" value="-654.5" lower_limit="-1405" upper_limit="-214"/>
                    <measurement group_id="O9" value="-490.0" lower_limit="-928" upper_limit="-429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D1- Pre-Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="7"/>
                    <count group_id="O8" value="8"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-421.0" lower_limit="-729" upper_limit="-31"/>
                    <measurement group_id="O2" value="-26.0" lower_limit="-538" upper_limit="104"/>
                    <measurement group_id="O3" value="-414.0" lower_limit="-1101" upper_limit="630"/>
                    <measurement group_id="O4" value="-153.0" lower_limit="-774" upper_limit="-38"/>
                    <measurement group_id="O5" value="-185.0" lower_limit="-865" upper_limit="-177"/>
                    <measurement group_id="O6" value="-627.0" lower_limit="-632" upper_limit="-622"/>
                    <measurement group_id="O7" value="-294.0" lower_limit="-500" upper_limit="308"/>
                    <measurement group_id="O8" value="-185.5" lower_limit="-1155" upper_limit="430"/>
                    <measurement group_id="O9" value="11.5" lower_limit="-104" upper_limit="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D1- 4 hours post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="3"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="-167.5" lower_limit="-229" upper_limit="-106"/>
                    <measurement group_id="O5" value="-336.5" lower_limit="-507" upper_limit="-166"/>
                    <measurement group_id="O6" value="-567.0" lower_limit="-615" upper_limit="-372"/>
                    <measurement group_id="O9" value="-465.5" lower_limit="-911" upper_limit="254"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes From Baseline in ICOS Ligand+ B Cells</title>
        <description>Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in ICOS ligand+ B cells in the tumor and peripheral blood. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes in MFI by flow cytometry. An increase in MFI between patient samples corresponds to an increase in cell surface ICOS expression on target cell subsets.</description>
        <time_frame>From baseline up to pre-dose and 4 hours post dose on C1D1, 72 hours post dose on C1D4, and pre-dose on C2D1 (approximately 31 months)</time_frame>
        <population>Biomarker Evaluable Participants: All treated participants with available biomarker data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Changes From Baseline in ICOS Ligand+ B Cells</title>
          <description>Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in ICOS ligand+ B cells in the tumor and peripheral blood. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes in MFI by flow cytometry. An increase in MFI between patient samples corresponds to an increase in cell surface ICOS expression on target cell subsets.</description>
          <population>Biomarker Evaluable Participants: All treated participants with available biomarker data</population>
          <units>Median of Fluorescence of ICOS (MFI)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="9"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="10"/>
                <count group_id="O9" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Response</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="10"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="9"/>
                    <count group_id="O8" value="10"/>
                    <count group_id="O9" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.0" lower_limit="-94" upper_limit="185"/>
                    <measurement group_id="O2" value="-33.0" lower_limit="-70" upper_limit="67"/>
                    <measurement group_id="O3" value="2.5" lower_limit="-99" upper_limit="95"/>
                    <measurement group_id="O4" value="40.5" lower_limit="-90" upper_limit="127"/>
                    <measurement group_id="O5" value="-60.5" lower_limit="-171" upper_limit="74"/>
                    <measurement group_id="O6" value="57.0" lower_limit="-100" upper_limit="182"/>
                    <measurement group_id="O7" value="-15.0" lower_limit="-79" upper_limit="70"/>
                    <measurement group_id="O8" value="-11.5" lower_limit="-113" upper_limit="41"/>
                    <measurement group_id="O9" value="39.0" lower_limit="-56" upper_limit="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C1D1 - 4 hours post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="2"/>
                    <count group_id="O8" value="10"/>
                    <count group_id="O9" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-106.0" lower_limit="-106" upper_limit="-106"/>
                    <measurement group_id="O2" value="-2.0" lower_limit="-2" upper_limit="-2"/>
                    <measurement group_id="O3" value="-3.0" lower_limit="-48" upper_limit="37"/>
                    <measurement group_id="O4" value="1.0" lower_limit="-9" upper_limit="23"/>
                    <measurement group_id="O5" value="-13.5" lower_limit="-55" upper_limit="0"/>
                    <measurement group_id="O6" value="9.5" lower_limit="-16" upper_limit="99"/>
                    <measurement group_id="O7" value="3.5" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="O8" value="0.0" lower_limit="-14" upper_limit="37"/>
                    <measurement group_id="O9" value="-6.0" lower_limit="-21" upper_limit="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C1D4- 72 hours post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="2"/>
                    <count group_id="O8" value="10"/>
                    <count group_id="O9" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="-181" upper_limit="58"/>
                    <measurement group_id="O2" value="102.0" lower_limit="-28" upper_limit="190"/>
                    <measurement group_id="O3" value="170.0" lower_limit="118" upper_limit="210"/>
                    <measurement group_id="O4" value="37.0" lower_limit="-143" upper_limit="231"/>
                    <measurement group_id="O5" value="64.5" lower_limit="-71" upper_limit="127"/>
                    <measurement group_id="O6" value="29.0" lower_limit="-106" upper_limit="88"/>
                    <measurement group_id="O7" value="90.0" lower_limit="17" upper_limit="163"/>
                    <measurement group_id="O8" value="70.0" lower_limit="3" upper_limit="143"/>
                    <measurement group_id="O9" value="33.5" lower_limit="-28" upper_limit="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D1- Pre dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="7"/>
                    <count group_id="O8" value="8"/>
                    <count group_id="O9" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.0" lower_limit="-267" upper_limit="54"/>
                    <measurement group_id="O2" value="-24.0" lower_limit="-211" upper_limit="24"/>
                    <measurement group_id="O3" value="96.0" lower_limit="-167" upper_limit="207"/>
                    <measurement group_id="O4" value="-17.0" lower_limit="-100" upper_limit="170"/>
                    <measurement group_id="O5" value="103.5" lower_limit="-39" upper_limit="216"/>
                    <measurement group_id="O6" value="-28.0" lower_limit="-74" upper_limit="18"/>
                    <measurement group_id="O7" value="-9.0" lower_limit="-129" upper_limit="83"/>
                    <measurement group_id="O8" value="61.5" lower_limit="-20" upper_limit="186"/>
                    <measurement group_id="O9" value="-17.0" lower_limit="-175" upper_limit="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax)</title>
        <description>Cmax is the maximum serum concentration that a drug achieves after the drug has been administered and before the administration of a second dose.</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax)</title>
          <description>Cmax is the maximum serum concentration that a drug achieves after the drug has been administered and before the administration of a second dose.</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="11"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="8"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="733" spread="NA">Geometric Coefficient of Variation not calculated. %CV=37</measurement>
                    <measurement group_id="O2" value="2250" spread="NA">Geometric Coefficient of Variation not calculated. %CV=20</measurement>
                    <measurement group_id="O3" value="6609" spread="NA">Geometric Coefficient of Variation not calculated. %CV=23</measurement>
                    <measurement group_id="O4" value="19524" spread="NA">Geometric Coefficient of Variation not calculated. %CV=28</measurement>
                    <measurement group_id="O5" value="41698" spread="NA">Geometric Coefficient of Variation not calculated. %CV=33</measurement>
                    <measurement group_id="O6" value="85905" spread="NA">Geometric Coefficient of Variation not calculated. %CV=37</measurement>
                    <measurement group_id="O7" value="5440" spread="NA">Geometric Coefficient of Variation not calculated. %CV=35</measurement>
                    <measurement group_id="O8" value="43309" spread="NA">Geometric Coefficient of Variation not calculated. %CV=28</measurement>
                    <measurement group_id="O9" value="3451" spread="NA">Geometric Coefficient of Variation not calculated. %CV=53</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="1"/>
                    <count group_id="O9" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1050" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="7220" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="23322" spread="NA">Geometric Coefficient of Variation not calculated. %CV=16</measurement>
                    <measurement group_id="O5" value="45054" spread="NA">Geometric Coefficient of Variation not calculated. %CV=36</measurement>
                    <measurement group_id="O6" value="91931" spread="NA">Geometric Coefficient of Variation not calculated. %CV=108</measurement>
                    <measurement group_id="O8" value="30200" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="2697" spread="NA">Geometric Coefficient of Variation not calculated. %CV=7</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1060" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="3168" spread="NA">Geometric Coefficient of Variation not calculated. %CV=12</measurement>
                    <measurement group_id="O4" value="15000" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="41700" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O6" value="76700" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="3880" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effective Elimination Half-Life (T-HALFeff)</title>
        <description>Effective elimination half-life that explains the degree of accumulation observed</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C2D1 and C3D1 (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Effective Elimination Half-Life (T-HALFeff)</title>
          <description>Effective elimination half-life that explains the degree of accumulation observed</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>Hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="0"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="212" spread="9.4"/>
                    <measurement group_id="O5" value="102" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="308" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trough Observed Serum Concentrations (Ctrough)</title>
        <description>Trough observed serum concentrations (Ctrough) is defined as the concentration reached by a drug immediately before the next dose is administered</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. Pre-dose on C5D1 and C6D1. Pre-dose and 0.5 hours post dose on C7D1. (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Observed Serum Concentrations (Ctrough)</title>
          <description>Trough observed serum concentrations (Ctrough) is defined as the concentration reached by a drug immediately before the next dose is administered</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="1"/>
                <count group_id="O8" value="1"/>
                <count group_id="O9" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="1"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="27.0" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="943" spread="584.4"/>
                    <measurement group_id="O5" value="1501" spread="1202.9"/>
                    <measurement group_id="O6" value="1491" spread="1287.3"/>
                    <measurement group_id="O7" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="1"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="27.2" spread="20.72"/>
                    <measurement group_id="O4" value="892" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="180" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O6" value="3150" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O7" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="1"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="504" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="800" spread="401.1"/>
                    <measurement group_id="O7" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="3300" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="1"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="12.5" spread="NA">Standard deviation not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Maximum Observed Serum Concentration (Tmax)</title>
        <description>Tmax is defined as the amount of time that a drug is present at the maximum concentration in serum</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximum Observed Serum Concentration (Tmax)</title>
          <description>Tmax is defined as the amount of time that a drug is present at the maximum concentration in serum</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="11"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="8"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="0.067" upper_limit="4.22"/>
                    <measurement group_id="O2" value="0.283" lower_limit="0.133" upper_limit="4.00"/>
                    <measurement group_id="O3" value="0.534" lower_limit="0.467" upper_limit="4.50"/>
                    <measurement group_id="O4" value="1.25" lower_limit="0.467" upper_limit="21.7"/>
                    <measurement group_id="O5" value="3.88" lower_limit="0.467" upper_limit="24.0"/>
                    <measurement group_id="O6" value="4.00" lower_limit="0.500" upper_limit="24.0"/>
                    <measurement group_id="O7" value="2.88" lower_limit="0.467" upper_limit="4.50"/>
                    <measurement group_id="O8" value="1.02" lower_limit="0.483" upper_limit="18.9"/>
                    <measurement group_id="O9" value="0.600" lower_limit="0.467" upper_limit="22.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="1"/>
                    <count group_id="O9" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.600" lower_limit="0.600" upper_limit="0.600"/>
                    <measurement group_id="O3" value="0.967" lower_limit="0.967" upper_limit="0.967"/>
                    <measurement group_id="O4" value="4.00" lower_limit="0.483" upper_limit="4.00"/>
                    <measurement group_id="O5" value="1.00" lower_limit="0.433" upper_limit="4.52"/>
                    <measurement group_id="O6" value="4.00" lower_limit="0.383" upper_limit="4.00"/>
                    <measurement group_id="O8" value="2.83" lower_limit="2.83" upper_limit="2.83"/>
                    <measurement group_id="O9" value="2.24" lower_limit="0.483" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.133" lower_limit="0.133" upper_limit="0.133"/>
                    <measurement group_id="O3" value="0.534" lower_limit="0.517" upper_limit="0.550"/>
                    <measurement group_id="O4" value="0.467" lower_limit="0.467" upper_limit="0.467"/>
                    <measurement group_id="O5" value="1.03" lower_limit="1.03" upper_limit="1.03"/>
                    <measurement group_id="O6" value="0.967" lower_limit="0.967" upper_limit="0.967"/>
                    <measurement group_id="O9" value="0.500" lower_limit="0.500" upper_limit="0.500"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration [AUC (0-T)]</title>
        <description>AUC(0-t) (partial AUC) is defined as the area under the concentration-time curve from dosing (time 0) to time t. AUC(0-t) may be computed for one or more values of t, with specific values of t determined after observing the data.</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration [AUC (0-T)]</title>
          <description>AUC(0-t) (partial AUC) is defined as the area under the concentration-time curve from dosing (time 0) to time t. AUC(0-t) may be computed for one or more values of t, with specific values of t determined after observing the data.</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="11"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="8"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33704" spread="NA">Geometric Coefficient of Variation not calculated. %CV=12</measurement>
                    <measurement group_id="O2" value="175228" spread="NA">Geometric Coefficient of Variation not calculated. %CV=33</measurement>
                    <measurement group_id="O3" value="682168" spread="NA">Geometric Coefficient of Variation not calculated. %CV=23</measurement>
                    <measurement group_id="O4" value="1951486" spread="NA">Geometric Coefficient of Variation not calculated. %CV=52</measurement>
                    <measurement group_id="O5" value="4966612" spread="NA">Geometric Coefficient of Variation not calculated. %CV=53</measurement>
                    <measurement group_id="O6" value="8346408" spread="NA">Geometric Coefficient of Variation not calculated. %CV=25</measurement>
                    <measurement group_id="O7" value="370356" spread="NA">Geometric Coefficient of Variation not calculated. %CV=41</measurement>
                    <measurement group_id="O8" value="4805561" spread="NA">Geometric Coefficient of Variation not calculated. %CV=60</measurement>
                    <measurement group_id="O9" value="277927" spread="NA">Geometric Coefficient of Variation not calculated. %CV=54</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="5"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="1"/>
                    <count group_id="O9" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="13921" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="933038" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="3534177" spread="NA">Geometric Coefficient of Variation not calculated. %CV=14</measurement>
                    <measurement group_id="O5" value="5887547" spread="NA">Geometric Coefficient of Variation not calculated. %CV=45</measurement>
                    <measurement group_id="O6" value="4070442" spread="NA">Geometric Coefficient of Variation not calculated. %CV=60</measurement>
                    <measurement group_id="O8" value="2528949" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="35464" spread="NA">Geometric Coefficient of Variation not calculated. %CV=39</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="18442" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="81982" spread="NA">Geometric Coefficient of Variation not calculated. %CV=128</measurement>
                    <measurement group_id="O4" value="2727643" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="5157593" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O6" value="7511434" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="55178" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Concentration-Time Curve in 1 Dosing Interval [AUC (TAU)]</title>
        <description>AUC (TAU) is defined as the area under the plasma concentration-time curve from time zero to the end of the dosing interval</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-Time Curve in 1 Dosing Interval [AUC (TAU)]</title>
          <description>AUC (TAU) is defined as the area under the plasma concentration-time curve from time zero to the end of the dosing interval</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>h*ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="9"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="11"/>
                <count group_id="O9" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="8"/>
                    <count group_id="O8" value="11"/>
                    <count group_id="O9" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37392" spread="NA">Geometric Coefficient of Variation not calculated. %CV=18</measurement>
                    <measurement group_id="O2" value="189031" spread="NA">Geometric Coefficient of Variation not calculated. %CV=32</measurement>
                    <measurement group_id="O3" value="704072" spread="NA">Geometric Coefficient of Variation not calculated. %CV=22</measurement>
                    <measurement group_id="O4" value="1992589" spread="NA">Geometric Coefficient of Variation not calculated. %CV=51</measurement>
                    <measurement group_id="O5" value="5148217" spread="NA">Geometric Coefficient of Variation not calculated. %CV=51</measurement>
                    <measurement group_id="O6" value="8740936" spread="NA">Geometric Coefficient of Variation not calculated. %CV=26</measurement>
                    <measurement group_id="O7" value="404651" spread="NA">Geometric Coefficient of Variation not calculated. %CV=42</measurement>
                    <measurement group_id="O8" value="5006775" spread="NA">Geometric Coefficient of Variation not calculated. %CV=67</measurement>
                    <measurement group_id="O9" value="301365" spread="NA">Geometric Coefficient of Variation not calculated. %CV=53</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="933038" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="3693517" spread="NA">Geometric Coefficient of Variation not calculated. %CV=12</measurement>
                    <measurement group_id="O5" value="5766681" spread="NA">Geometric Coefficient of Variation not calculated. %CV=55</measurement>
                    <measurement group_id="O6" value="10833374" spread="NA">Geometric Coefficient of Variation not calculated. %CV=4</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="19007" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="373429" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="2727643" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="5157593" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Body Clearance (CLT)</title>
        <description>CLT is defined as the elimination of the drug from the body</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Total Body Clearance (CLT)</title>
          <description>CLT is defined as the elimination of the drug from the body</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>mL/h</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="26.8" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="21.7" spread="NA">Geometric Coefficient of Variation not calculated. %CV=13</measurement>
                    <measurement group_id="O5" value="34.7" spread="NA">Geometric Coefficient of Variation not calculated. %CV=59</measurement>
                    <measurement group_id="O6" value="36.9" spread="NA">Geometric Coefficient of Variation not calculated. %CV=4</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="421" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="29.3" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="38.8" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Concentration Over a Dosing Interval (Css-avg)</title>
        <description>Css-avg is defined as the average concentration over a dosing interval (AUC[TAU]/tau)&#xD;
Note: Coefficient of variation is reported in lieu of geometric coefficient of variation</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Average Concentration Over a Dosing Interval (Css-avg)</title>
          <description>Css-avg is defined as the average concentration over a dosing interval (AUC[TAU]/tau)&#xD;
Note: Coefficient of variation is reported in lieu of geometric coefficient of variation</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="2"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="1397" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="5499" spread="NA">Geometric Coefficient of Variation not calculated. %CV=12</measurement>
                    <measurement group_id="O5" value="8581" spread="NA">Geometric Coefficient of Variation not calculated. %CV=55</measurement>
                    <measurement group_id="O6" value="16115" spread="NA">Geometric Coefficient of Variation not calculated. %CV=4</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="28.3" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="556" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="4065" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="7666" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Index - Area Under Curve (AI-AUC)</title>
        <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose. The area under curve is defined as the area under the plot of plasma concentration of a drug versus time after dosage which reflects the extent of exposure to a drug and its clearance rate from the body.</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Index - Area Under Curve (AI-AUC)</title>
          <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose. The area under curve is defined as the area under the plot of plasma concentration of a drug versus time after dosage which reflects the extent of exposure to a drug and its clearance rate from the body.</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="1.07" spread="NA">Geometric Coefficient of Variation not calculated. %CV=9</measurement>
                    <measurement group_id="O5" value="0.856" spread="NA">Geometric Coefficient of Variation not calculated. %CV=14</measurement>
                    <measurement group_id="O6" value="0.953" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.100" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="0.808" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="1.28" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Index - Cmax (AI-Cmax)</title>
        <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose. Cmax is the maximum serum concentration that a drug achieves after the drug has been administered and before the administration of a second dose.</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. (Approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Index - Cmax (AI-Cmax)</title>
          <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose. Cmax is the maximum serum concentration that a drug achieves after the drug has been administered and before the administration of a second dose.</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="4"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="1"/>
                <count group_id="O9" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="4"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.475" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="1.19" spread="NA">Geometric Coefficient of Variation not calculated. %CV=12</measurement>
                    <measurement group_id="O5" value="0.951" spread="NA">Geometric Coefficient of Variation not calculated. %CV=5</measurement>
                    <measurement group_id="O6" value="0.861" spread="NA">Geometric Coefficient of Variation not calculated. %CV=86</measurement>
                    <measurement group_id="O9" value="0.687" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.457" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O3" value="0.309" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="0.920" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="1.11" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O6" value="0.940" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O9" value="1.11" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="1"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O8" value="0.633" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Index - Concentrations at the End of Dosing Interval (AI-CTAU)</title>
        <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose.</description>
        <time_frame>Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. (Approximately 31 months)</time_frame>
        <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
        <group_list>
          <group group_id="O1">
            <title>Preliminary - BMS-986226 2 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
          </group>
          <group group_id="O2">
            <title>Preliminary - BMS-986226 8 mg</title>
            <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
          </group>
          <group group_id="O3">
            <title>Part A - BMS-986226 25 mg</title>
            <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O4">
            <title>Part A - BMS-986226 80 mg</title>
            <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O5">
            <title>Part A - BMS-986226 200 mg</title>
            <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O6">
            <title>Part A - BMS-986226 400 mg</title>
            <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
          </group>
          <group group_id="O7">
            <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O8">
            <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
          <group group_id="O9">
            <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
            <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Index - Concentrations at the End of Dosing Interval (AI-CTAU)</title>
          <description>Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose.</description>
          <population>Evaluable PK Population: All treated participants who have evaluable serum concentration-time data</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="4"/>
                <count group_id="O6" value="1"/>
                <count group_id="O7" value="0"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>C2D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="3"/>
                    <count group_id="O5" value="4"/>
                    <count group_id="O6" value="1"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0.640" spread="NA">Geometric Coefficient of Variation not calculated. %CV=10</measurement>
                    <measurement group_id="O5" value="1.12" spread="NA">Geometric Coefficient of Variation not calculated. %CV=114</measurement>
                    <measurement group_id="O6" value="1.38" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C3D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="NA" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O4" value="0.391" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                    <measurement group_id="O5" value="33.3" spread="NA">Geometric Coefficient of Variation not calculated. %CV not calculated due to insufficient number of participants with evaluable responses.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C4D1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                    <count group_id="O7" value="0"/>
                    <count group_id="O8" value="0"/>
                    <count group_id="O9" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 50 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 31 months)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Preliminary - BMS-986226 2 mg</title>
          <description>Preliminary safety cohort participants received BMS-986226 2 mg every 4 weeks</description>
        </group>
        <group group_id="E2">
          <title>Preliminary - BMS-986226 8 mg</title>
          <description>Preliminary safety cohort participants received BMS-986226 8 mg every 4 weeks</description>
        </group>
        <group group_id="E3">
          <title>Part A - BMS-986226 25 mg</title>
          <description>Part A cohort participants received BMS-986226 25 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="E4">
          <title>Part A - BMS-986226 80 mg</title>
          <description>Part A cohort participants received BMS-986226 80 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="E5">
          <title>Part A - BMS-986226 200 mg</title>
          <description>Part A cohort participants received BMS-986226 200 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="E6">
          <title>Part A - BMS-986226 400 mg</title>
          <description>Part A cohort participants received BMS-986226 400 mg every 4 weeks for 24 weeks</description>
        </group>
        <group group_id="E7">
          <title>Part C1 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C1 cohort participants received BMS-986226 25 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
        <group group_id="E8">
          <title>Part C1 - BMS-986226 200 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C1 cohort participants received BMS-986226 200 mg every 12 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
        <group group_id="E9">
          <title>Part C2 - BMS-986226 25 mg + Ipilimumab 3 mg/kg</title>
          <description>Part C2 cohort participants received BMS-986226 25 mg every 4 weeks plus Ipilimumab 3 mg/kg every 4 weeks</description>
        </group>
        <group group_id="E10">
          <title>Total</title>
          <description>Total treated participants</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="53" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="50" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Biliary obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pelvic infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </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" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="33" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tumour associated fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Assisted suicide</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>24.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="79" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="14" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Periorbital oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="15" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="10" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="16" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="14" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="25" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="10" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Portal hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="40" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="15" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>CD4 lymphocytes decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="15" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </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" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Renal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema genital</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="80"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="80"/>
              </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>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study CA021002 was terminated because the Sponsor discontinued further development of BMS-986226. The decision for the study closure was not related to any safety concerns associated with BMS-986226.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please Email</phone>
      <email>Clinical.Trials@bms.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/NCT03251924
org study id: CA021-002
secondary id: 2017-000238-73
nct id: NCT03251924
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to investigate BMS-986226 administered alone or in combination
      with nivolumab or ipilimumab.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Number of Participants Experiencing Adverse Events (AEs)
time frame: From first dose up to 100 days post last dose, up to approximately 31 months
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participants Experiencing Serious Adverse Events (SAEs)
time frame: From first dose up to 100 days post last dose, up to approximately 31 months
description: Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization.
measure: The Number of Participants Experiencing Adverse Events (AEs) Meeting Dose Limiting Toxicity (DLT) Criteria
time frame: From first dose up to 100 days post last dose, up to approximately 31 months
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Dose limiting toxicity (DLT) is defined based on the incidence, intensity, and duration of AEs for which no clear alternative cause is identified. The DLT period will be 28 days (4 weeks) in the Preliminary Safety Cohorts. Any toxicities that occur beyond the 4-week DLT period will also be considered in dose-level decisions. For the purpose of participant management, any AE that meets DLT criteria, regardless of the cycle in which it occurs, will lead to discontinuation of study treatment. AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
measure: The Number of Participants Experiencing Adverse Events Leading to Discontinuation
time frame: From first dose up to 100 days post last dose, up to approximately 31 months
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participants Experiencing Adverse Events Resulting in Death
time frame: From first dose up to 100 days post last dose, up to approximately 31 months
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participants Experiencing Clinical Laboratory Abnormalities
time frame: From first dose up to 30 days post last dose (approximately 28 months)
description: The number of participants experiencing abnormal laboratory results of Grade 3 or higher. Laboratory values will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 with Grade 3=severe and Grade 4=life threatening.
measure: Objective Response Rate (ORR)
time frame: From first dose up to documented disease progression, up to 48 months
description: ORR is defined as the percentage of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) as assessed by investigator per RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. BOR for a participant is defined as the best response designation recorded between the date of first dose (or date of randomization) and the date of first objectively documented progression per RECIST 1.1 or the date of subsequent therapy, whichever occurs first.
measure: Median Duration of Response (DOR)
time frame: From first dose up to the date of the first objectively documented tumor progression or death, whichever occurs first (up to approximately 24 months)
description: DOR for a participant with confirmed response is defined as the time from the date of first response CR or PR to the date of first objectively documented tumor progression as determined using RECIST v1.1 or death due to any cause, whichever occurs first. Participant who remain alive and have not progressed will be censored on the date of their last tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression will be censored at the last tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
measure: Progression Free Survival (PFS) Rate at 24 Weeks
time frame: At 24 weeks
description: The PFSR is defined as the Kaplan Meier estimate of percentage of treated participants remaining progression free and surviving at the prespecified timepoint of 24 weeks since the first dosing date. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: The appearance of 1 or more new lesions is also considered progression.)
measure: Number of Participants With Anti-Drug Antibodies (ADA) for BMS-986226
time frame: Predose on cycles 1-6, post dose on C1D15, and 30, 60, and 100 days post last dose (up to approximately 31 months)
description: ADA for BMS-986226 is defined as the number of participants found to have seroconverted or boosted their pre-existing ADA during the study period. Baseline ADA positive is defined as ADA is detected in the last sample before initiation of treatment. ADA positive is defined as 1) an ADA detected (positive seroconversion) sample in a participant for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.
measure: Changes From Baseline in Cell Surface ICOS Expression on T Cells
time frame: From baseline up to pre-dose and 4 hours post dose on C1D1 and pre-dose and 4 hours post dose on C2D1 (approximately 31 months)
description: Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in cell surface Inducible Costimulator (ICOS) expression on T cells. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes in MFI by flow cytometry. An increase in MFI between patient samples corresponds to an increase in cell surface ICOS expression on target cell subsets.
measure: Changes From Baseline in ICOS Ligand+ B Cells
time frame: From baseline up to pre-dose and 4 hours post dose on C1D1, 72 hours post dose on C1D4, and pre-dose on C2D1 (approximately 31 months)
description: Summary measures of changes in Median of Fluorescence of ICOS (MFI) from baseline to the last evaluable time point in ICOS ligand+ B cells in the tumor and peripheral blood. Baseline = last non missing value prior or on to the first dosing. MFI is a unit for median fluorescence intensity. This unit allows for measurement of relative expression of cell surface markers by a flow cytometer. For the ICOS expression assay, whole blood samples collected from patients on study were incubated with fluorescently labeled antibodies that specifically bind to ICOS. Samples were then analyzed for changes in MFI by flow cytometry. An increase in MFI between patient samples corresponds to an increase in cell surface ICOS expression on target cell subsets.
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)
description: Cmax is the maximum serum concentration that a drug achieves after the drug has been administered and before the administration of a second dose.
measure: Effective Elimination Half-Life (T-HALFeff)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C2D1 and C3D1 (approximately 31 months)
description: Effective elimination half-life that explains the degree of accumulation observed
measure: Trough Observed Serum Concentrations (Ctrough)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. Pre-dose on C5D1 and C6D1. Pre-dose and 0.5 hours post dose on C7D1. (approximately 31 months)
description: Trough observed serum concentrations (Ctrough) is defined as the concentration reached by a drug immediately before the next dose is administered
measure: Time of Maximum Observed Serum Concentration (Tmax)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)
description: Tmax is defined as the amount of time that a drug is present at the maximum concentration in serum
measure: Area Under Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration [AUC (0-T)]
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)
description: AUC(0-t) (partial AUC) is defined as the area under the concentration-time curve from dosing (time 0) to time t. AUC(0-t) may be computed for one or more values of t, with specific values of t determined after observing the data.
measure: Area Under the Concentration-Time Curve in 1 Dosing Interval [AUC (TAU)]
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)
description: AUC (TAU) is defined as the area under the plasma concentration-time curve from time zero to the end of the dosing interval
measure: Total Body Clearance (CLT)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)
description: CLT is defined as the elimination of the drug from the body
measure: Average Concentration Over a Dosing Interval (Css-avg)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)
description: Css-avg is defined as the average concentration over a dosing interval (AUC[TAU]/tau)
Note: Coefficient of variation is reported in lieu of geometric coefficient of variation
measure: Accumulation Index - Area Under Curve (AI-AUC)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1, and C3D1 (approximately 31 months)
description: Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose. The area under curve is defined as the area under the plot of plasma concentration of a drug versus time after dosage which reflects the extent of exposure to a drug and its clearance rate from the body.
measure: Accumulation Index - Cmax (AI-Cmax)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. (Approximately 31 months)
description: Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose. Cmax is the maximum serum concentration that a drug achieves after the drug has been administered and before the administration of a second dose.
measure: Accumulation Index - Concentrations at the End of Dosing Interval (AI-CTAU)
time frame: Pre-dose, 0.5, 4, 24, 72, 168, 336, 504 hours post dose on C1D1, C2D1 and C3D1. Pre-dose and 0.5 post dose on C4D1. (Approximately 31 months)
description: Accumulation Index is defined as the extent of drug accumulation and determined by the ratio of plasma concentration at plateau over plasma concentration after the first dose.
arm group label: BMS-986226
arm group type: Experimental
description: administered intravenously
arm group label: BMS-986226 and Nivolumab
arm group type: Experimental
description: administered intravenously
arm group label: BMS-986226 and Ipilimumab
arm group type: Experimental
description: administered intravenously
intervention type: Drug
intervention name: BMS-986226
description: specified dose on specified days
arm group label: BMS-986226
arm group label: BMS-986226 and Ipilimumab
arm group label: BMS-986226 and Nivolumab
intervention type: Biological
intervention name: Nivolumab
description: specified dose on specified days
arm group label: BMS-986226 and Nivolumab
other name: BMS-936558
other name: PD-1 receptor blocking monoclonal antibody [mAb]
other name: Opdivo
intervention type: Biological
intervention name: Ipilimumab
description: specified dose on specified days
arm group label: BMS-986226 and Ipilimumab
other name: BMS-734016
other name: MDX010
other name: Checkpoint blocking antibody that recognizes CTLA-4
other name: Yervoy
intervention type: Biological
intervention name: Tetanus Vaccine
description: specified dose on specified days
arm group label: BMS-986226
arm group label: BMS-986226 and Ipilimumab
arm group label: BMS-986226 and Nivolumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Canada
country: Spain
country: Switzerland
country: United States
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.BMSStudyConnect.com
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Nivolumab
mesh term: Ipilimumab
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Blocking
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study CA021002 was terminated because the Sponsor discontinued further development of BMS-986226. The decision for the study closure was not related to any safety concerns associated with BMS-986226.
point of contact: 