<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/NCT01714739</url>
  </required_header>
  <id_info>
    <org_study_id>CA223-001</org_study_id>
    <nct_id>NCT01714739</nct_id>
  </id_info>
  <brief_title>A Study of an Anti-KIR Antibody Lirilumab in Combination With an Anti-PD1 Antibody Nivolumab and Nivolumab Plus an Anti-CTLA-4 Ipilimumab Antibody in Patients With Advanced Solid Tumors</brief_title>
  <official_title>A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory 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>
      To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab&#xD;
      (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting&#xD;
      toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to&#xD;
      assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab&#xD;
      (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid&#xD;
      tumors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 7, 2012</start_date>
  <completion_date type="Actual">December 13, 2019</completion_date>
  <primary_completion_date type="Actual">December 13, 2019</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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participant Deaths in the Study - Parts 1, 2 and 5</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>The number of participants who died.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a &gt;= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>From first dose up to approximately 2.5 years</time_frame>
    <description>Objective Response Rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR for a participant was derived using investigator-provided tumor measurements per RECIST v1.1. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR) - Part 3</measure>
    <time_frame>From first dose up to approximately 2.5 years</time_frame>
    <description>Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. All participants will be monitored by radiographic assessment every 8 weeks from first dose to Week 48, and every 12 weeks thereafter until PD or treatment discontinuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Duration of Response (mDOR) - Parts 3 and 5</measure>
    <time_frame>From first dose to the date of the first documented tumor progression as determined or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)</time_frame>
    <description>DOR 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 were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Response (mTTR) - Part 3</measure>
    <time_frame>From date of first dose of study medication to the date of the first documented objective response (up to approximately 2.5 years)</time_frame>
    <description>TTR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With &gt;=50% or &gt;=80% Tumor Reduction - Parts 3 and 5</measure>
    <time_frame>From first dose until progressive disease (PD) or treatment discontinuation, whichever occurs earlier. (Up to approximately 2.5 years)</time_frame>
    <description>Depth of response is defined as the target tumor burden percent change from baseline at nadir for each participant as measured by the number of participants with &gt;= 50% and &gt;= 80% tumor reduction. Tumor assessments are performed every 8 weeks from first dose date for 48 weeks, and then every 12 weeks thereafter until progressive disease (PD) or treatment discontinuation, whichever occurs earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) - Part 3</measure>
    <time_frame>From date of first dose of study medication to the date of death for any cause. (Up to approximately 2.5 years)</time_frame>
    <description>Overall Survival (OS) is defined as the time from date of first dose of study medication to the date of death for any cause. A participant who has not died will be censored at last known date alive. OS for a participant who initiated new cancer treatment, will also be censored at the date of the new treatment initiation. Estimated by Kaplan-Meier Method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) - Part 3</measure>
    <time_frame>From first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)</time_frame>
    <description>PFS is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Participants who died without a reported prior progression was considered to have progressed on the date of their death. Participants alive with no progression were censored on the last evaluable tumor assessment date. Participants who started subsequent therapy with no prior progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent therapy. Participants with no post-baseline tumor assessment and alive were censored on the date of first dose. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival Rate (PFSR) at 6 Months - Part 3</measure>
    <time_frame>At 6 months after first dose</time_frame>
    <description>Percentage of treated participants remaining progression free and surviving at 6 months. For those participants who remain alive and have not progressed, PFS will be censored on the date of the last tumor assessment. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) - Part 3</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs) - Part 3</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part 3</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participant Deaths in the Study - Part 3</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>The number of participants who died.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Laboratory Test Abnormalities - Part 3</measure>
    <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
    <description>Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a &gt;= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5</measure>
    <time_frame>From first dose to 100 days after last dose (up to approximately 126 weeks)</time_frame>
    <description>Number of participants observed as ADA positive at baseline, ADA positive (post-baseline), and ADA negative (post-baseline). Baseline is defined as the last sample before initiation of treatment&#xD;
Baseline ADA Positive Participant: A participant with baseline ADA positive sample.&#xD;
ADA Positive Participant: Participant with &gt;=1 ADA +ve sample relative to baseline (baseline ADA -ve, or ADA titer &gt;= 9-fold for Lirilumab and &gt;= 4-fold for Nivolumab relative to baseline +ve titer) at any time after first dose during the defined observation time period.&#xD;
ADA Negative Participant: A participant with no ADA positive sample after the initiation of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose Day 1 (Cycles 1 ,3 ,5, 7, 9), Pre-dose Day 29 (Cycle 1, 2)</time_frame>
    <description>The number of participants with 1% or 5% PD-L1 expression in the tumor cell membrane. Participants are considered positive if they show &gt;=1% or &gt;= 5% PD-L1 expression in the tumor cell membrane and negative if they show &lt; 1% or &lt; 5%. PD-L1 expression is defined as the percent of tumor cells demonstrating plasma membrane PDL1 staining of any intensity. PD-L1 will be evaluated by immunohistochemistry (IHC).&#xD;
PD-L1 status at pretreatment is considered positive if any pretreatment sample is positive.&#xD;
PDL1= programmed cell death ligand 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half-life (T-HALF) - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance Per Time (CLT) - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Pasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time ([AUC(INF)] - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. AUC(INF) was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution During Terminal Phase (Vz) - Parts 1, 2 and 5</measure>
    <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. VZ was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri)</measure>
    <time_frame>Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ctrough - Parts 1, 2 and 5 (Liri)</measure>
    <time_frame>Pre-dose on cycle 1 day 29 and Pre-dose and end of infusion on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Nivo)</measure>
    <time_frame>Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ctrough - Parts 1, 2 and 5 (Nivo)</measure>
    <time_frame>336 hours post dose on cycle 1 day 1 (cycle 1 day 15) and pre-dose and end of infusion on cycle 2 day 29.</time_frame>
    <description>Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">337</enrollment>
  <condition>CANCER,NOS</condition>
  <arm_group>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2 and 3: Cohort Expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 4: Cohort Expansion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 5 and 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab (Study Part 6 Removed; No Subjects Enrolled)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lirilumab</intervention_name>
    <description>Specified dose on specified days.</description>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_label>Part 2 and 3: Cohort Expansion</arm_group_label>
    <arm_group_label>Part 4: Cohort Expansion</arm_group_label>
    <arm_group_label>Part 5 and 6</arm_group_label>
    <other_name>BMS-986015</other_name>
    <other_name>IPH-2102</other_name>
    <other_name>ANTI-KIR (Killer-cell Immunoglobulin-like Receptors)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified dose on specified days.</description>
    <arm_group_label>Part 1</arm_group_label>
    <arm_group_label>Part 2 and 3: Cohort Expansion</arm_group_label>
    <arm_group_label>Part 4: Cohort Expansion</arm_group_label>
    <arm_group_label>Part 5 and 6</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>ANTI-PD1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Specified dose on specified days.</description>
    <arm_group_label>Part 5 and 6</arm_group_label>
    <other_name>BMS-734016</other_name>
    <other_name>Anti-CTLA4</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  During dose escalation, subjects with advanced solid tumors (except for primary CNS&#xD;
             metastases) that have progressed following at least one standard regimen&#xD;
&#xD;
          -  During cohort expansion, subjects with various solid tumors that have received at&#xD;
             least one and no more than 5 prior treatment regimens&#xD;
&#xD;
          -  Subjects must have measurable disease&#xD;
&#xD;
          -  Subject must consent to provide previously collected tumor tissue&#xD;
&#xD;
          -  Women and men ≥18 years of age with performance status of 0 or 1&#xD;
&#xD;
          -  At least 4 weeks since any previous treatment for cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active or chronic autoimmune diseases&#xD;
&#xD;
          -  Uncontrolled or significant cardiovascular disease&#xD;
&#xD;
          -  Chronic hepatitis (except for subjects with hepatocellular carcinoma)&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Active Central nervous system (CNS) metastases&#xD;
&#xD;
          -  Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome((HIV/AIDS)&#xD;
&#xD;
          -  Positive test for Hepatitis B virus surface antigen or Hepatitis C antibody (except&#xD;
             for subjects with hepatocellular carcinoma)&#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>Ucsf</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Affiliates - Ocala</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins</name>
      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Med Ctr</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Med Ctr</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Eye and Ear Institute</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Cancer Center</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Central Austin Cancer Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78731</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Texas Medical Branch Of Galveston</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Center</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Bordeaux</city>
        <zip>33075</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Lyon Cedex 08</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Nice Cedex 2</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Nazionale Tumori Milano</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0038</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital Graubuenden</name>
      <address>
        <city>Chur</city>
        <zip>7000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois</name>
      <address>
        <city>Lausanne</city>
        <zip>1011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Germany</country>
    <country>Singapore</country>
  </removed_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/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <results_first_submitted>December 8, 2022</results_first_submitted>
  <results_first_submitted_qc>January 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 2, 2023</results_first_posted>
  <disposition_first_submitted>December 10, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>December 10, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 14, 2020</disposition_first_posted>
  <last_update_submitted>January 17, 2023</last_update_submitted>
  <last_update_submitted_qc>January 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 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>Immunoglobulins</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT01714739/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT01714739/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Part 4 and Part 6 of the study were removed from the protocol study design prior to enrolling any subjects.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1/2 Liri 0.1 + Nivo 3</title>
          <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="P2">
          <title>Part 1/2: Liri 0.3 + Nivo 3</title>
          <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="P3">
          <title>Part 1/2: Liri 1 + Nivo 3</title>
          <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="P4">
          <title>Part 1/2: Liri 3 + Nivo 3</title>
          <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="P5">
          <title>Part 3: PBO + Nivo 240</title>
          <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
        </group>
        <group group_id="P6">
          <title>Part 3: Liri 240 + Nivo 240</title>
          <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
        </group>
        <group group_id="P7">
          <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
          <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="287"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="264"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="204"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study drug toxicity</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event unrelated to drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to stop therapy</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="6"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</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="8"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Maximum clinical benefit</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Poor/non-comliance</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="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer meets study criteria</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_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason</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="3"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 1/2 Liri 0.1 + Nivo 3</title>
          <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="B2">
          <title>Part 1/2: Liri 0.3 + Nivo 3</title>
          <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="B3">
          <title>Part 1/2: Liri 1 + Nivo 3</title>
          <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="B4">
          <title>Part 1/2: Liri 3 + Nivo 3</title>
          <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="B5">
          <title>Part 3: PBO + Nivo 240</title>
          <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
        </group>
        <group group_id="B6">
          <title>Part 3: Liri 240 + Nivo 240</title>
          <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
        </group>
        <group group_id="B7">
          <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
          <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
        </group>
        <group group_id="B8">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="4"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="287"/>
            <count group_id="B5" value="2"/>
            <count group_id="B6" value="3"/>
            <count group_id="B7" value="10"/>
            <count group_id="B8" value="337"/>
          </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="53.3" spread="12.09"/>
                    <measurement group_id="B2" value="58.1" spread="13.11"/>
                    <measurement group_id="B3" value="58.7" spread="16.85"/>
                    <measurement group_id="B4" value="59.7" spread="11.37"/>
                    <measurement group_id="B5" value="65.5" spread="10.61"/>
                    <measurement group_id="B6" value="55.3" spread="21.08"/>
                    <measurement group_id="B7" value="67.1" spread="10.40"/>
                    <measurement group_id="B8" value="59.7" spread="11.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <description>Age categorical</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt; 65 years old</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="184"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="215"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;= 65 years old</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="103"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="122"/>
                  </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="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="80"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="207"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="9"/>
                    <measurement group_id="B8" value="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="175"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="219"/>
                  </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="0"/>
                    <measurement group_id="B4" value="106"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="2"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Race</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="237"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="10"/>
                    <measurement group_id="B8" value="287"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/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="10"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American Indian / 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="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</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="29"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.</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="4"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="287"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="284"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5</title>
        <description>A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5</title>
          <description>A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.</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="4"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="287"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="205"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5</title>
        <description>Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5</title>
          <description>Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.</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="4"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="287"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="49"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participant Deaths in the Study - Parts 1, 2 and 5</title>
        <description>The number of participants who died.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participant Deaths in the Study - Parts 1, 2 and 5</title>
          <description>The number of participants who died.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Parts 1, 2 and 5.</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="4"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="287"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="219"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5</title>
        <description>Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a &gt;= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Parts 1, 2 and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5</title>
          <description>Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a &gt;= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.</description>
          <population>All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Parts 1, 2 and 5.</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="4"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="287"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absolute Neutrophil Count - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="286"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Neutrophil Count - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="286"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Amino Transferase (ALT) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="277"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Amino Transferase (ALT) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="277"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="256"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="256"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase (ALP) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="277"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="6"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase (ALP) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="277"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amylase, Total - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="274"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="8"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amylase, Total - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="274"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APTT - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="25"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APTT - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="25"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase (AST) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="277"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="4"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase (AST) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="277"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Total - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="277"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Total - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="287"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Corrected - Grade 3</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="61"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Corrected - Grade 4</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="61"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Ionized - Grade 3</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="2"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Ionized - Grade 4</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="2"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Total - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="279"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="6"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Total - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="279"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="4"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (CK) - Grade 3</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="1"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (CK) - Grade 4</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="1"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="278"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="278"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fibrinogen - Grade 3</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="47"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fibrinogen - Grade 4</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="47"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-Glutamyl Transferase (GGT) - Grade 3</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="1"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-Glutamyl Transferase (GGT) - Grade 4</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="1"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Fasting Serum - Grade 3</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="71"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Fasting Serum - Grade 4</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="71"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Serum - Grade 3</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="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Serum - Grade 4</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="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="24"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="3"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="3"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total (Colorimetric Assay) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="286"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="18"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total (Colorimetric Assay) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="275"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="7"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total (Turbidimetric Assay) - Grade 3</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="5"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total (Turbidimetric Assay) - Grade 4</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="5"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Absolute) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="64"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Absolute) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="9"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium, Serum - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="276"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium, Serum - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="276"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (Absolute) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (Absolute) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pH, Arterial Blood - Grade 3</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="285"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pH, Arterial Blood - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="285"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphorus, Inorganic - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="269"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphorus, Inorganic - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="269"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="281"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Serum - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="278"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="6"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Serum - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="278"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium Serum - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="278"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="26"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium Serum - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="278"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>Objective Response Rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR for a participant was derived using investigator-provided tumor measurements per RECIST v1.1. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>From first dose up to approximately 2.5 years</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O6">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O7">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>Objective Response Rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR for a participant was derived using investigator-provided tumor measurements per RECIST v1.1. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</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="4"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="287"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="3"/>
                <count group_id="O7" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="0.6" upper_limit="80.6"/>
                    <measurement group_id="O2" value="37.5" lower_limit="15.2" upper_limit="64.6"/>
                    <measurement group_id="O3" value="40.0" lower_limit="16.3" upper_limit="67.7"/>
                    <measurement group_id="O4" value="14.6" lower_limit="10.8" upper_limit="19.3"/>
                    <measurement group_id="O5" value="50.0" lower_limit="1.3" upper_limit="98.7"/>
                    <measurement group_id="O6" value="0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O7" value="0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR) - Part 3</title>
        <description>Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. All participants will be monitored by radiographic assessment every 8 weeks from first dose to Week 48, and every 12 weeks thereafter until PD or treatment discontinuation.</description>
        <time_frame>From first dose up to approximately 2.5 years</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR) - Part 3</title>
          <description>Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. All participants will be monitored by radiographic assessment every 8 weeks from first dose to Week 48, and every 12 weeks thereafter until PD or treatment discontinuation.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Part 3.</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="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="1.3" upper_limit="98.7"/>
                    <measurement group_id="O2" value="33.3" lower_limit="0.8" upper_limit="90.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Duration of Response (mDOR) - Parts 3 and 5</title>
        <description>DOR 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 were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>From first dose to the date of the first documented tumor progression as determined or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)</time_frame>
        <population>All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Parts 3 and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O3">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Median Duration of Response (mDOR) - Parts 3 and 5</title>
          <description>DOR 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 were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
          <population>All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Parts 3 and 5.</population>
          <units>weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="40.0" upper_limit="40.0">Insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Response (mTTR) - Part 3</title>
        <description>TTR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>From date of first dose of study medication to the date of the first documented objective response (up to approximately 2.5 years)</time_frame>
        <population>All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Response (mTTR) - Part 3</title>
          <description>TTR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt; 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
          <population>All treated participants with a confirmed BOR of CR or PR. Pre-specified for data to be collected only in Part 3.</population>
          <units>Weeks</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.10" lower_limit="8.1" upper_limit="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With &gt;=50% or &gt;=80% Tumor Reduction - Parts 3 and 5</title>
        <description>Depth of response is defined as the target tumor burden percent change from baseline at nadir for each participant as measured by the number of participants with &gt;= 50% and &gt;= 80% tumor reduction. Tumor assessments are performed every 8 weeks from first dose date for 48 weeks, and then every 12 weeks thereafter until progressive disease (PD) or treatment discontinuation, whichever occurs earlier.</description>
        <time_frame>From first dose until progressive disease (PD) or treatment discontinuation, whichever occurs earlier. (Up to approximately 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Parts 3 and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O3">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With &gt;=50% or &gt;=80% Tumor Reduction - Parts 3 and 5</title>
          <description>Depth of response is defined as the target tumor burden percent change from baseline at nadir for each participant as measured by the number of participants with &gt;= 50% and &gt;= 80% tumor reduction. Tumor assessments are performed every 8 weeks from first dose date for 48 weeks, and then every 12 weeks thereafter until progressive disease (PD) or treatment discontinuation, whichever occurs earlier.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Parts 3 and 5.</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="2"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>WITH &gt;=50% TUMOR REDUCTION</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WITH &gt;=80% TUMOR REDUCTION</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS) - Part 3</title>
        <description>Overall Survival (OS) is defined as the time from date of first dose of study medication to the date of death for any cause. A participant who has not died will be censored at last known date alive. OS for a participant who initiated new cancer treatment, will also be censored at the date of the new treatment initiation. Estimated by Kaplan-Meier Method.</description>
        <time_frame>From date of first dose of study medication to the date of death for any cause. (Up to approximately 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS) - Part 3</title>
          <description>Overall Survival (OS) is defined as the time from date of first dose of study medication to the date of death for any cause. A participant who has not died will be censored at last known date alive. OS for a participant who initiated new cancer treatment, will also be censored at the date of the new treatment initiation. Estimated by Kaplan-Meier Method.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Part 3.</population>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0.2" upper_limit="1.2">Time point at which % of survivors drops below 50% has not been reached due to insufficient number of events and/or follow up</measurement>
                    <measurement group_id="O2" value="0.3" lower_limit="0.1" upper_limit="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) - Part 3</title>
        <description>PFS is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Participants who died without a reported prior progression was considered to have progressed on the date of their death. Participants alive with no progression were censored on the last evaluable tumor assessment date. Participants who started subsequent therapy with no prior progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent therapy. Participants with no post-baseline tumor assessment and alive were censored on the date of first dose. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.</description>
        <time_frame>From first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) - Part 3</title>
          <description>PFS is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Participants who died without a reported prior progression was considered to have progressed on the date of their death. Participants alive with no progression were censored on the last evaluable tumor assessment date. Participants who started subsequent therapy with no prior progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent therapy. Participants with no post-baseline tumor assessment and alive were censored on the date of first dose. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Part 3.</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="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="1.1" upper_limit="11.0">Insufficient number of events</measurement>
                    <measurement group_id="O2" value="1.6" lower_limit="1.1" upper_limit="7.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival Rate (PFSR) at 6 Months - Part 3</title>
        <description>Percentage of treated participants remaining progression free and surviving at 6 months. For those participants who remain alive and have not progressed, PFS will be censored on the date of the last tumor assessment. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.</description>
        <time_frame>At 6 months after first dose</time_frame>
        <population>All treated participants in Part 3</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival Rate (PFSR) at 6 Months - Part 3</title>
          <description>Percentage of treated participants remaining progression free and surviving at 6 months. For those participants who remain alive and have not progressed, PFS will be censored on the date of the last tumor assessment. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.</description>
          <population>All treated participants in Part 3</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="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="0.6" upper_limit="91.0"/>
                    <measurement group_id="O2" value="33.3" lower_limit="0.9" upper_limit="77.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) - Part 3</title>
        <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) - Part 3</title>
          <description>An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Part 3.</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="2"/>
                <count group_id="O2" value="3"/>
              </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs) - Part 3</title>
        <description>A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs) - Part 3</title>
          <description>A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Part 3.</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="2"/>
                <count group_id="O2" value="3"/>
              </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part 3</title>
        <description>Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part 3</title>
          <description>Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Part 3.</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="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participant Deaths in the Study - Part 3</title>
        <description>The number of participants who died.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participant Deaths in the Study - Part 3</title>
          <description>The number of participants who died.</description>
          <population>All treated participants. Pre-specified for data to be collected only in Part 3.</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="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Laboratory Test Abnormalities - Part 3</title>
        <description>Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a &gt;= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.</description>
        <time_frame>From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)</time_frame>
        <population>All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Part 3.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3: PBO + Nivo 240</title>
            <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
          <group group_id="O2">
            <title>Part 3: Liri 240 + Nivo 240</title>
            <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Laboratory Test Abnormalities - Part 3</title>
          <description>Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a &gt;= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.</description>
          <population>All treated participants with available laboratory test measurements. Pre-specified for data to be collected only in Part 3.</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="2"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Absolute Neutrophil Count - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute Neutrophil Count - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Amino Transferase (ALT) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine Amino Transferase (ALT) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin - Grade 3</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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin - Grade 4</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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase (ALP) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase (ALP) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amylase, Total - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amylase, Total - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APTT - Grade 3</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>APTT - Grade 4</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase (AST) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate Aminotransferase (AST) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Total - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Total - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Corrected - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Corrected - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Ionized - Grade 3</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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Ionized - Grade 4</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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Total - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Total - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (CK) - Grade 3</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Creatine Kinase (CK) - Grade 4</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Creatinine - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fibrinogen - Grade 3</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Fibrinogen - Grade 4</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>G-Glutamyl Transferase (GGT) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>G-Glutamyl Transferase (GGT) - Grade 4</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Glucose, Fasting Serum - Grade 3</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Glucose, Fasting Serum - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Serum - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Serum - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total (Colorimetric Assay) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total (Colorimetric Assay) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lipase, Total (Turbidimetric Assay) - Grade 3</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Lipase, Total (Turbidimetric Assay) - Grade 4</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Lymphocytes (Absolute) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Absolute) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium, Serum - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium, Serum - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (Absolute) - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (Absolute) - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pH, Arterial Blood - Grade 3</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>pH, Arterial Blood - Grade 4</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_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Phosphorus, Inorganic - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphorus, Inorganic - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Serum - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Serum - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium Serum - Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium Serum - Grade 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5</title>
        <description>Number of participants observed as ADA positive at baseline, ADA positive (post-baseline), and ADA negative (post-baseline). Baseline is defined as the last sample before initiation of treatment&#xD;
Baseline ADA Positive Participant: A participant with baseline ADA positive sample.&#xD;
ADA Positive Participant: Participant with &gt;=1 ADA +ve sample relative to baseline (baseline ADA -ve, or ADA titer &gt;= 9-fold for Lirilumab and &gt;= 4-fold for Nivolumab relative to baseline +ve titer) at any time after first dose during the defined observation time period.&#xD;
ADA Negative Participant: A participant with no ADA positive sample after the initiation of treatment.</description>
        <time_frame>From first dose to 100 days after last dose (up to approximately 126 weeks)</time_frame>
        <population>All participants who receive at least 1 dose of drug and have at least 1 ADA sample available. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5</title>
          <description>Number of participants observed as ADA positive at baseline, ADA positive (post-baseline), and ADA negative (post-baseline). Baseline is defined as the last sample before initiation of treatment&#xD;
Baseline ADA Positive Participant: A participant with baseline ADA positive sample.&#xD;
ADA Positive Participant: Participant with &gt;=1 ADA +ve sample relative to baseline (baseline ADA -ve, or ADA titer &gt;= 9-fold for Lirilumab and &gt;= 4-fold for Nivolumab relative to baseline +ve titer) at any time after first dose during the defined observation time period.&#xD;
ADA Negative Participant: A participant with no ADA positive sample after the initiation of treatment.</description>
          <population>All participants who receive at least 1 dose of drug and have at least 1 ADA sample available. Pre-specified for data to be collected only in Parts 1, 2, and 5.</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="4"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="255"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline ADA Positive - Liri</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="254"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="21"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA Positive - Liri</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="254"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="20"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA Negative - Liri</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="254"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="234"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline ADA Positive - Nivo</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="255"/>
                    <count group_id="O5" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="14"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA Positive - Nivo</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="255"/>
                    <count group_id="O5" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="43"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA Negative - Nivo</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="255"/>
                    <count group_id="O5" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="212"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline ADA Positive - Ipi</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="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA Positive - Ipi</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="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ADA Negative - Ipi</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="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5</title>
        <description>The number of participants with 1% or 5% PD-L1 expression in the tumor cell membrane. Participants are considered positive if they show &gt;=1% or &gt;= 5% PD-L1 expression in the tumor cell membrane and negative if they show &lt; 1% or &lt; 5%. PD-L1 expression is defined as the percent of tumor cells demonstrating plasma membrane PDL1 staining of any intensity. PD-L1 will be evaluated by immunohistochemistry (IHC).&#xD;
PD-L1 status at pretreatment is considered positive if any pretreatment sample is positive.&#xD;
PDL1= programmed cell death ligand 1</description>
        <time_frame>Pre-dose Day 1 (Cycles 1 ,3 ,5, 7, 9), Pre-dose Day 29 (Cycle 1, 2)</time_frame>
        <population>All treated participants with available archival tumor sample and with pre- and on-treatment biopsies. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5</title>
          <description>The number of participants with 1% or 5% PD-L1 expression in the tumor cell membrane. Participants are considered positive if they show &gt;=1% or &gt;= 5% PD-L1 expression in the tumor cell membrane and negative if they show &lt; 1% or &lt; 5%. PD-L1 expression is defined as the percent of tumor cells demonstrating plasma membrane PDL1 staining of any intensity. PD-L1 will be evaluated by immunohistochemistry (IHC).&#xD;
PD-L1 status at pretreatment is considered positive if any pretreatment sample is positive.&#xD;
PDL1= programmed cell death ligand 1</description>
          <population>All treated participants with available archival tumor sample and with pre- and on-treatment biopsies. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <units>Number of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="231"/>
                <count group_id="O5" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PD-L1 1 percent - positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="127"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 1 percent - negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="104"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 5 percent - positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="77"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 5 percent - negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="154"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</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="4"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="249"/>
                <count group_id="O5" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="249"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2223.10" spread="NA">NA = Geometric CV not applicable; %CV = 27</measurement>
                    <measurement group_id="O2" value="6509.35" spread="NA">NA = Geometric CV not applicable; %CV = 27</measurement>
                    <measurement group_id="O3" value="22250.96" spread="NA">NA = Geometric CV not applicable; %CV = 29</measurement>
                    <measurement group_id="O4" value="52034.18" spread="NA">NA = Geometric CV not applicable; %CV = 33</measurement>
                    <measurement group_id="O5" value="65333.91" spread="NA">NA = Geometric CV not applicable; %CV = 3</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="111"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2277.39" spread="NA">NA = Geometric CV not applicable; %CV = 6</measurement>
                    <measurement group_id="O2" value="7286.95" spread="NA">NA = Geometric CV not applicable; %CV = 24</measurement>
                    <measurement group_id="O3" value="25623.89" spread="NA">NA = Geometric CV not applicable; %CV = 20</measurement>
                    <measurement group_id="O4" value="69224.70" spread="NA">NA = Geometric CV not applicable; %CV = 26</measurement>
                    <measurement group_id="O5" value="81600.00" spread="NA">NA = only 1 participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <units>hour*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="4"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="249"/>
                <count group_id="O5" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="249"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="360903.09" spread="NA">NA = Geometric CV not applicable; %CV = 23</measurement>
                    <measurement group_id="O2" value="734836.53" spread="NA">NA = Geometric CV not applicable; %CV = 45</measurement>
                    <measurement group_id="O3" value="4462883.03" spread="NA">NA = Geometric CV not applicable; %CV = 35</measurement>
                    <measurement group_id="O4" value="9647500.52" spread="NA">NA = Geometric CV not applicable; %CV = 37</measurement>
                    <measurement group_id="O5" value="8819119.61" spread="NA">NA = Geometric CV not applicable; %CV = 29</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="111"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="569516.79" spread="NA">NA = Geometric CV not applicable; %CV = 26</measurement>
                    <measurement group_id="O2" value="1367259.80" spread="NA">NA = Geometric CV not applicable; %CV = 67</measurement>
                    <measurement group_id="O3" value="6547184.03" spread="NA">NA = Geometric CV not applicable; %CV = 37</measurement>
                    <measurement group_id="O4" value="11731186.91" spread="NA">NA = Geometric CV not applicable; %CV = 51</measurement>
                    <measurement group_id="O5" value="9958714.89" spread="NA">NA = not applicable, only 1 participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <units>hour*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="4"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="209"/>
                <count group_id="O5" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="209"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366418.73" spread="NA">NA = Geometric CV not applicable; %CV = 21</measurement>
                    <measurement group_id="O2" value="1155363.50" spread="NA">NA = Geometric CV not applicable; %CV = 33</measurement>
                    <measurement group_id="O3" value="4462883.03" spread="NA">NA = Geometric CV not applicable; %CV = 35</measurement>
                    <measurement group_id="O4" value="11418017.10" spread="NA">NA = Geometric CV not applicable; %CV = 28</measurement>
                    <measurement group_id="O5" value="10843715.48" spread="NA">NA = not applicable, only 1 participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="569516.79" spread="NA">NA = Geometric CV not applicable; %CV = 26</measurement>
                    <measurement group_id="O2" value="1726615.52" spread="NA">NA = Geometric CV not applicable; %CV = 44</measurement>
                    <measurement group_id="O3" value="6712959.58" spread="NA">NA = Geometric CV not applicable; %CV = 31</measurement>
                    <measurement group_id="O4" value="18504162.18" spread="NA">NA = Geometric CV not applicable; %CV = 28</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data.</description>
        <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <units>hour</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="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="249"/>
                <count group_id="O5" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="249"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.13" lower_limit="1.0" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.05" lower_limit="0.8" upper_limit="21.7"/>
                    <measurement group_id="O3" value="1.07" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O4" value="1.22" lower_limit="0.1" upper_limit="161.3"/>
                    <measurement group_id="O5" value="1.03" lower_limit="1.0" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="111"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" lower_limit="1.0" upper_limit="1.5"/>
                    <measurement group_id="O2" value="1.02" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O3" value="1.13" lower_limit="0.9" upper_limit="25.5"/>
                    <measurement group_id="O4" value="1.18" lower_limit="0.8" upper_limit="168.1"/>
                    <measurement group_id="O5" value="1.33" lower_limit="1.33" upper_limit="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Half-life (T-HALF) - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data.</description>
        <time_frame>Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Half-life (T-HALF) - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <units>hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="94"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="383.96" spread="235.421"/>
                    <measurement group_id="O2" value="273.89" spread="234.588"/>
                    <measurement group_id="O3" value="515.07" spread="361.525"/>
                    <measurement group_id="O4" value="281.31" spread="237.236"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance Per Time (CLT) - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance Per Time (CLT) - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <units>liter per hour</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="3"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="75"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="NA">NA = Geometric CV not applicable; %CV = 22</measurement>
                    <measurement group_id="O2" value="0.01" spread="NA">NA = Geometric CV not applicable; %CV = 38</measurement>
                    <measurement group_id="O3" value="0.01" spread="NA">NA = Geometric CV not applicable; %CV = 35</measurement>
                    <measurement group_id="O4" value="0.01" spread="NA">NA = Geometric CV not applicable; %CV = 30</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</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="4"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="209"/>
                <count group_id="O5" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="209"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.62" spread="NA">NA = Geometric CV not applicable; %CV = 77</measurement>
                    <measurement group_id="O2" value="521.28" spread="NA">NA = Geometric CV not applicable; %CV = 60</measurement>
                    <measurement group_id="O3" value="2572.90" spread="NA">NA = Geometric CV not applicable; %CV = 47</measurement>
                    <measurement group_id="O4" value="6195.04" spread="NA">NA = Geometric CV not applicable; %CV = 45</measurement>
                    <measurement group_id="O5" value="5190.00" spread="NA">NA = not applicable, only 1 participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="10"/>
                    <count group_id="O4" value="74"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="358.55" spread="NA">NA = Geometric CV not applicable; %CV = 68</measurement>
                    <measurement group_id="O2" value="1180.39" spread="NA">NA = Geometric CV not applicable; %CV = 65</measurement>
                    <measurement group_id="O3" value="4827.27" spread="NA">NA = Geometric CV not applicable; %CV = 32</measurement>
                    <measurement group_id="O4" value="11392.89" spread="NA">NA = Geometric CV not applicable; %CV = 45</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Pasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time ([AUC(INF)] - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. AUC(INF) was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.</description>
        <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data samples. Due to limited sampling in this study, data was not collected. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Pasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time ([AUC(INF)] - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. AUC(INF) was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data samples. Due to limited sampling in this study, data was not collected. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
            </class>
            <class>
              <title>Cycle 2</title>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Volume of Distribution During Terminal Phase (Vz) - Parts 1, 2 and 5</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. VZ was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.</description>
        <time_frame>Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data samples. Due to limited sampling in this study, data was not collected. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Volume of Distribution During Terminal Phase (Vz) - Parts 1, 2 and 5</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. VZ was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data samples. Due to limited sampling in this study, data was not collected. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <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_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1</title>
            </class>
            <class>
              <title>Cycle 2</title>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri)</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri)</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</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="4"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="249"/>
                <count group_id="O5" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="249"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2223.10" spread="NA">NA = Geometric CV not applicable; %CV = 27</measurement>
                    <measurement group_id="O2" value="6434.65" spread="NA">NA = Geometric CV not applicable; %CV = 28</measurement>
                    <measurement group_id="O3" value="22250.96" spread="NA">NA = Geometric CV not applicable; %CV = 29</measurement>
                    <measurement group_id="O4" value="45163.87" spread="NA">NA = Geometric CV not applicable; %CV = 38</measurement>
                    <measurement group_id="O5" value="65333.91" spread="NA">NA = Geometric CV not applicable; %CV = 3</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="110"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2277.39" spread="NA">NA = Geometric CV not applicable; %CV = 6</measurement>
                    <measurement group_id="O2" value="7286.95" spread="NA">NA = Geometric CV not applicable; %CV = 24</measurement>
                    <measurement group_id="O3" value="25185.06" spread="NA">NA = Geometric CV not applicable; %CV = 20</measurement>
                    <measurement group_id="O4" value="65874.20" spread="NA">NA = Geometric CV not applicable; %CV = 30</measurement>
                    <measurement group_id="O5" value="81600.00" spread="NA">NA = not applicable, only 1 participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ctrough - Parts 1, 2 and 5 (Liri)</title>
        <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>Pre-dose on cycle 1 day 29 and Pre-dose and end of infusion on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Ctrough - Parts 1, 2 and 5 (Liri)</title>
          <description>Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of lirilumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</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="3"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="200"/>
                <count group_id="O5" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="200"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="192.29" spread="NA">NA = Geometric CV not applicable; %CV = 42</measurement>
                    <measurement group_id="O2" value="521.28" spread="NA">NA = Geometric CV not applicable; %CV = 60</measurement>
                    <measurement group_id="O3" value="2572.90" spread="NA">NA = Geometric CV not applicable; %CV = 47</measurement>
                    <measurement group_id="O4" value="6195.08" spread="NA">NA = Geometric CV not applicable; %CV = 45</measurement>
                    <measurement group_id="O5" value="5190.00" spread="NA">NA = not applicable, only 1 participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="110"/>
                    <count group_id="O5" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="327.50" spread="NA">NA = Geometric CV not applicable; %CV = 85</measurement>
                    <measurement group_id="O2" value="1069.84" spread="NA">NA = Geometric CV not applicable; %CV = 63</measurement>
                    <measurement group_id="O3" value="4592.95" spread="NA">NA = Geometric CV not applicable; %CV = 32</measurement>
                    <measurement group_id="O4" value="10865.91" spread="NA">NA = Geometric CV not applicable; %CV = 45</measurement>
                    <measurement group_id="O5" value="19100.00" spread="NA">NA = not applicable, only 1 participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Nivo)</title>
        <description>Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Nivo)</title>
          <description>Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <units>μg/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="4"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="253"/>
                <count group_id="O5" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="253"/>
                    <count group_id="O5" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.16" spread="NA">NA = Geometric CV not applicable; %CV = 31</measurement>
                    <measurement group_id="O2" value="66.33" spread="NA">NA = Geometric CV not applicable; %CV = 16</measurement>
                    <measurement group_id="O3" value="66.16" spread="NA">NA = Geometric CV not applicable; %CV = 24</measurement>
                    <measurement group_id="O4" value="52.48" spread="NA">NA = Geometric CV not applicable; %CV = 25</measurement>
                    <measurement group_id="O5" value="44.75" spread="NA">NA = Geometric CV not applicable; %CV = 15</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="111"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.47" spread="NA">NA = Geometric CV not applicable; %CV = 16</measurement>
                    <measurement group_id="O2" value="114.89" spread="NA">NA = Geometric CV not applicable; %CV = 28</measurement>
                    <measurement group_id="O3" value="116.08" spread="NA">NA = Geometric CV not applicable; %CV = 17</measurement>
                    <measurement group_id="O4" value="99.75" spread="NA">NA = Geometric CV not applicable; %CV = 25</measurement>
                    <measurement group_id="O5" value="115.37" spread="NA">NA = Geometric CV not applicable; %CV = 7</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ctrough - Parts 1, 2 and 5 (Nivo)</title>
        <description>Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
        <time_frame>336 hours post dose on cycle 1 day 1 (cycle 1 day 15) and pre-dose and end of infusion on cycle 2 day 29.</time_frame>
        <population>All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1/2 Liri 0.1 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O2">
            <title>Part 1/2: Liri 0.3 + Nivo 3</title>
            <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O3">
            <title>Part 1/2: Liri 1 + Nivo 3</title>
            <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O4">
            <title>Part 1/2: Liri 3 + Nivo 3</title>
            <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
          </group>
          <group group_id="O5">
            <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
            <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
          </group>
        </group_list>
        <measure>
          <title>Ctrough - Parts 1, 2 and 5 (Nivo)</title>
          <description>Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.</description>
          <population>All treated participants who received at least 1 dose of nivolumab and have available serum concentration data. Pre-specified for data to be collected only in Parts 1, 2, and 5.</population>
          <units>μg/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="4"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="244"/>
                <count group_id="O5" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="244"/>
                    <count group_id="O5" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.15" spread="NA">NA = Geometric CV not applicable; %CV = 16</measurement>
                    <measurement group_id="O2" value="20.14" spread="NA">NA = Geometric CV not applicable; %CV = 24</measurement>
                    <measurement group_id="O3" value="21.36" spread="NA">NA = Geometric CV not applicable; %CV = 24</measurement>
                    <measurement group_id="O4" value="15.81" spread="NA">NA = Geometric CV not applicable; %CV = 32</measurement>
                    <measurement group_id="O5" value="17.30" spread="NA">NA = Geometric CV not applicable; %CV = 19</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 29</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="123"/>
                    <count group_id="O5" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.67" spread="NA">NA = Geometric CV not applicable; %CV = 42</measurement>
                    <measurement group_id="O2" value="62.18" spread="NA">NA = Geometric CV not applicable; %CV = 38</measurement>
                    <measurement group_id="O3" value="71.31" spread="NA">NA = Geometric CV not applicable; %CV = 21</measurement>
                    <measurement group_id="O4" value="50.07" spread="NA">NA = Geometric CV not applicable; %CV = 32</measurement>
                    <measurement group_id="O5" value="62.62" spread="NA">NA = Geometric CV not applicable; %CV = 17</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 2.5 years). SAEs and Other AEs were assessed from first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Part 1/2 Liri 0.1 + Nivo 3</title>
          <description>Participants receive Lirilumab 0.1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="E2">
          <title>Part 1/2: Liri 0.3 + Nivo 3</title>
          <description>Participants receive Lirilumab 0.3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="E3">
          <title>Part 1/2: Liri 1 + Nivo 3</title>
          <description>Participants receive Lirilumab 1 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="E4">
          <title>Part 1/2: Liri 3 + Nivo 3</title>
          <description>Participants receive Lirilumab 3 mg/kg every 4 weeks (Q4W) and Nivolumab 3 mg/kg every 2 weeks (Q2W) for twelve 8-week treatment cycles.</description>
        </group>
        <group group_id="E5">
          <title>Part 3: PBO + Nivo 240</title>
          <description>Participants receive Placebo every 4 weeks (Q4W) and a flat dose of nivolumab monotherapy (240mg) every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
        </group>
        <group group_id="E6">
          <title>Part 3: Liri 240 + Nivo 240</title>
          <description>Participants receive Lirilumab 240 mg every 4 weeks (Q4W) and a flat dose of nivolumab 240 mg every 2 weeks (Q2W) for 8-week cycles until progressive disease.</description>
        </group>
        <group group_id="E7">
          <title>Part 5: Liri 3 + Nivo 3 + Ipi 1</title>
          <description>Participants receive Lirilumab 3 mg/kg IV every 4 weeks (Q4W), Nivolumab 3 mg/kg IV every 2 weeks (Q2W), and Ipilimumab 1 mg/kg IV every 6 weeks (Q6W) for 12-week cycles until progressive disease</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="219" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="205" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymph node haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Splenic haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Autoimmune pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastric haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Salivary gland fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Small intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tongue haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Adverse drug reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Secretion discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hepatic haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal wall abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Actinomycosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cellulitis orbital</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infective thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Psoas abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Device placement issue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Osteoradionecrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Radiation skin injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Stoma site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tracheal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vascular procedure complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Feeding disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infected neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malignant melanoma in situ</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="109" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malignant pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Metastases to bone</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Metastases to spine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Carotid artery aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Central nervous system haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Coma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Embolic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypercapnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Immune-mediated pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Laryngeal dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper airway obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Arterial rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="271" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Agranulocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="70" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>External ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cataract nuclear</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chorioretinal atrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chorioretinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eye movement disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lagophthalmos</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Meibomian gland dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Retinal deposits</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Strabismus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Swelling of eyelid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vitreous detachment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="60" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="66" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="29" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Melaena</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="62" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="43" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="43" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Device related thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Early satiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="144" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="29" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="69" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Type IV hypersensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fungal disease carrier</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Genital infection fungal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ophthalmic herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </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="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood magnesium increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood testosterone decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>CD4 lymphocytes decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave amplitude decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Heart sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Intraocular pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Prothrombin time ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="39" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="50" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="28" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="34" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Foot deformity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="26" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acrochordon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="16" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Consciousness fluctuating</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Facial paresis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="44" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myoclonus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Taste disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>VIth nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vulva cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vulval disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="62" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="47" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Immune-mediated pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lung opacity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal mucosal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Paranasal sinus hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pharyngeal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Melanocytic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Parapsoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="48" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="42" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Scab</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="287"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <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/NCT01714739
org study id: CA223-001
nct id: NCT01714739
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab
      (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting
      toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to
      assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab
      (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid
      tumors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of Participants With Adverse Events (AEs) - Parts 1, 2 and 5
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
measure: Number of Participants With Serious Adverse Events (SAEs) - Parts 1, 2 and 5
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Parts 1, 2 and 5
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participant Deaths in the Study - Parts 1, 2 and 5
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: The number of participants who died.
measure: Number of Participants With Clinical Laboratory Test Abnormalities - Parts 1, 2 and 5
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
measure: Objective Response Rate (ORR)
time frame: From first dose up to approximately 2.5 years
description: Objective Response Rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR). BOR for a participant was derived using investigator-provided tumor measurements per RECIST v1.1. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Disease Control Rate (DCR) - Part 3
time frame: From first dose up to approximately 2.5 years
description: Disease Control Rate (DCR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. All participants will be monitored by radiographic assessment every 8 weeks from first dose to Week 48, and every 12 weeks thereafter until PD or treatment discontinuation.
measure: Median Duration of Response (mDOR) - Parts 3 and 5
time frame: From first dose to the date of the first documented tumor progression as determined or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)
description: DOR 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 were censored on the date of their last evaluable tumor assessment. Participants who started subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent anticancer therapy. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Median Time to Response (mTTR) - Part 3
time frame: From date of first dose of study medication to the date of the first documented objective response (up to approximately 2.5 years)
description: TTR is defined as the time from the first dosing date to the date of the first documented objective response (CR or PR). CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: The Number of Participants With >=50% or >=80% Tumor Reduction - Parts 3 and 5
time frame: From first dose until progressive disease (PD) or treatment discontinuation, whichever occurs earlier. (Up to approximately 2.5 years)
description: Depth of response is defined as the target tumor burden percent change from baseline at nadir for each participant as measured by the number of participants with >= 50% and >= 80% tumor reduction. Tumor assessments are performed every 8 weeks from first dose date for 48 weeks, and then every 12 weeks thereafter until progressive disease (PD) or treatment discontinuation, whichever occurs earlier.
measure: Overall Survival (OS) - Part 3
time frame: From date of first dose of study medication to the date of death for any cause. (Up to approximately 2.5 years)
description: Overall Survival (OS) is defined as the time from date of first dose of study medication to the date of death for any cause. A participant who has not died will be censored at last known date alive. OS for a participant who initiated new cancer treatment, will also be censored at the date of the new treatment initiation. Estimated by Kaplan-Meier Method.
measure: Progression Free Survival (PFS) - Part 3
time frame: From first dose to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. (Up to approximately 2.5 years)
description: PFS is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Participants who died without a reported prior progression was considered to have progressed on the date of their death. Participants alive with no progression were censored on the last evaluable tumor assessment date. Participants who started subsequent therapy with no prior progression were censored at the last evaluable tumor assessment prior to initiation of the subsequent therapy. Participants with no post-baseline tumor assessment and alive were censored on the date of first dose. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.
measure: Progression Free Survival Rate (PFSR) at 6 Months - Part 3
time frame: At 6 months after first dose
description: Percentage of treated participants remaining progression free and surviving at 6 months. For those participants who remain alive and have not progressed, PFS will be censored on the date of the last tumor assessment. Progression is defined as At least a 20% increase in the sum of diameters of target lesions. The sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Clinical deterioration in the absence of radiographic evidence is not considered progression.
measure: Number of Participants With Adverse Events (AEs) - Part 3
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
measure: Number of Participants With Serious Adverse Events (SAEs) - Part 3
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation - Part 3
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: Number of participants that experienced an AE leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment.
measure: The Number of Participant Deaths in the Study - Part 3
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: The number of participants who died.
measure: Number of Participants With Clinical Laboratory Test Abnormalities - Part 3
time frame: From first dose to 150 days post last dose (up to an average of 51 weeks and a maximum of 2.5 years)
description: Number of participants that experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and thyroid panel abnormalities. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline. Laboratory tests are graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 where Grade 3 is severe, and Grade 4 is life threatening. Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
measure: Number of Participants With Anti-Drug Antibodies (ADA) - Parts 1, 2 and 5
time frame: From first dose to 100 days after last dose (up to approximately 126 weeks)
description: Number of participants observed as ADA positive at baseline, ADA positive (post-baseline), and ADA negative (post-baseline). Baseline is defined as the last sample before initiation of treatment
Baseline ADA Positive Participant: A participant with baseline ADA positive sample.
ADA Positive Participant: Participant with >=1 ADA +ve sample relative to baseline (baseline ADA -ve, or ADA titer >= 9-fold for Lirilumab and >= 4-fold for Nivolumab relative to baseline +ve titer) at any time after first dose during the defined observation time period.
ADA Negative Participant: A participant with no ADA positive sample after the initiation of treatment.
measure: The Number of Participants With PD-L1 Status at Pretreatment - Parts 1, 2 and 5
time frame: Pre-dose Day 1 (Cycles 1 ,3 ,5, 7, 9), Pre-dose Day 29 (Cycle 1, 2)
description: The number of participants with 1% or 5% PD-L1 expression in the tumor cell membrane. Participants are considered positive if they show >=1% or >= 5% PD-L1 expression in the tumor cell membrane and negative if they show < 1% or < 5%. PD-L1 expression is defined as the percent of tumor cells demonstrating plasma membrane PDL1 staining of any intensity. PD-L1 will be evaluated by immunohistochemistry (IHC).
PD-L1 status at pretreatment is considered positive if any pretreatment sample is positive.
PDL1= programmed cell death ligand 1
measure: Maximum Observed Plasma Concentration (Cmax) - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
measure: Area Under the Plasma Concentration-Time Curve in 1 Dosing Interval [AUC(TAU)] - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
measure: Time of Maximum Observed Concentration (Tmax) - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data.
measure: Half-life (T-HALF) - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data.
measure: Clearance Per Time (CLT) - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
measure: Trough Observed Concentration (Cmin, Also Known as CTAU) - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
measure: Area Under the Pasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time ([AUC(INF)] - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. AUC(INF) was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.
measure: Apparent Volume of Distribution During Terminal Phase (Vz) - Parts 1, 2 and 5
time frame: Pre-dose, end of infusion, 24, 168, and 336 hours post dose on day 1 cycle 1 and pre-dose on day 29 cycle 1. Pre-dose, end of infusion, 24 and 168 hours post dose on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. VZ was based on appropriate characterization of the elimination phase of the concentration versus time curve, which was unable to be performed due to limited sampling in this study.
measure: End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Liri)
time frame: Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
measure: Ctrough - Parts 1, 2 and 5 (Liri)
time frame: Pre-dose on cycle 1 day 29 and Pre-dose and end of infusion on cycle 2 day 29.
description: Pharmacokinetics of lirilumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
measure: End of Infusion Concentration (Ceoi) - Parts 1, 2 and 5 (Nivo)
time frame: Pre-dose and end of infusion on cycle 1 day 1 and cycle 2 day 29.
description: Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
measure: Ctrough - Parts 1, 2 and 5 (Nivo)
time frame: 336 hours post dose on cycle 1 day 1 (cycle 1 day 15) and pre-dose and end of infusion on cycle 2 day 29.
description: Pharmacokinetics of nivolumab were derived from serum concentration versus time data. Geometric CV data is not available, therefore the Arithmetic %CV is represented in the table below.
arm group label: Part 1
arm group type: Experimental
description: Dose Escalation and Initial Signal Detection in Multiple Solid Tumors - Nivolumab with Lirilumab
arm group label: Part 2 and 3: Cohort Expansion
arm group type: Experimental
description: In platinum-refractory recurrent or metastatic SCCHN - Nivolumab with or without Lirilumab
arm group label: Part 4: Cohort Expansion
arm group type: Experimental
description: Additional Signal Detection in Solid Tumors - Nivolumab with Lirilumab (Study Part 4 Removed; No Subjects Enrolled)
arm group label: Part 5 and 6
arm group type: Experimental
description: Safety Lead-In and Additional Signal Detection in Solid Tumors -- Nivolumab Plus Ipilimumab with Lirilumab (Study Part 6 Removed; No Subjects Enrolled)
intervention type: Drug
intervention name: Lirilumab
description: Specified dose on specified days.
arm group label: Part 1
arm group label: Part 2 and 3: Cohort Expansion
arm group label: Part 4: Cohort Expansion
arm group label: Part 5 and 6
other name: BMS-986015
other name: IPH-2102
other name: ANTI-KIR (Killer-cell Immunoglobulin-like Receptors)
intervention type: Drug
intervention name: Nivolumab
description: Specified dose on specified days.
arm group label: Part 1
arm group label: Part 2 and 3: Cohort Expansion
arm group label: Part 4: Cohort Expansion
arm group label: Part 5 and 6
other name: BMS-936558
other name: ANTI-PD1
intervention type: Drug
intervention name: Ipilimumab
description: Specified dose on specified days.
arm group label: Part 5 and 6
other name: BMS-734016
other name: Anti-CTLA4
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Canada
country: France
country: Italy
country: Spain
country: Switzerland
country: United States
country: Germany
country: Singapore
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Nivolumab
mesh term: Ipilimumab
mesh term: Immunoglobulins
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 