<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02967692</url>
  </required_header>
  <id_info>
    <org_study_id>CPDR001F2301</org_study_id>
    <secondary_id>2016-002794-35</secondary_id>
    <nct_id>NCT02967692</nct_id>
  </id_info>
  <brief_title>A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma</brief_title>
  <acronym>COMBI-i</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib Versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody&#xD;
      (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in&#xD;
      unresectable or metastatic BRAF V600 mutant melanoma&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed as a Phase III, multi-center study consisting of three parts:&#xD;
&#xD;
        -  Part 1, known as the Safety Run-in, is an open-label part aimed at determining the&#xD;
           recommended Phase III regimen (RP3R) of spartalizumab in combination with dabrafenib and&#xD;
           trametinib for previously untreated subjects with BRAF V600 mutant unresectable or&#xD;
           metastatic melanoma (Stage IIIC/IV per AJCC edition 7). In Part 1, spartalizumab was&#xD;
           administered at a starting dose level (DL1) of 400 mg every 4 weeks (Q4W), along with&#xD;
           fixed doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily). The&#xD;
           RP3R for Part 3 was determined using the Bayesian Logistic Regression Model (BLRM) with&#xD;
           escalation with overdose control (EWOC) criteria.&#xD;
&#xD;
        -  Part 2, referred to as the Biomarker Cohort, is an open-label section focused on&#xD;
           characterizing the kinetics of immune biomarkers and potential immune resistance&#xD;
           mechanisms. Part 2 started when the fourth subject in dose level 1 (DL1) of Part 1&#xD;
           completed approximately 4 weeks of study treatment, and fewer than 3 dose-limiting&#xD;
           toxicities (DLTs) were observed. Participants in Part 2 receive PDR001 (spartalizumab)&#xD;
           at a dosage of 400 mg Q4W, in combination with dabrafenib (150 mg BID) and trametinib (2&#xD;
           mg QD).&#xD;
&#xD;
        -  Part 3 is a double-blind, randomized, placebo-controlled phase that compares the&#xD;
           efficacy and safety of spartalizumab in combination with dabrafenib and trametinib to&#xD;
           placebo in combination with dabrafenib and trametinib. Part 3 was initiated after&#xD;
           determining the RP3R for the combination of spartalizumab with dabrafenib and trametinib&#xD;
           in Part 1. Subjects were randomized in a 1:1 ratio to receive either the RP3R dose of&#xD;
           spartalizumab identified in Part 1 or placebo, along with dabrafenib (150 mg BID) and&#xD;
           trametinib (2 mg QD).&#xD;
&#xD;
      For all parts of the study, the treatment is continued until the subject experiences any of&#xD;
      the following events: disease progression according to RECIST 1.1 as determined by the&#xD;
      Investigator, unacceptable toxicity, initiation of a new anti-neoplastic therapy, pregnancy,&#xD;
      withdrawal of consent, physician's decision, loss to follow-up, death, or termination of the&#xD;
      study by the Sponsor. Safety evaluations are conducted for all subjects for up to 150 days&#xD;
      after the last dose of spartalizumab/placebo (safety follow-up period).&#xD;
&#xD;
      Subjects who discontinue study treatment without disease progression as per RECIST 1.1&#xD;
      continue with tumor assessments according to the protocol until documented disease&#xD;
      progression, withdrawal of consent, loss to follow-up, or death, regardless of the initiation&#xD;
      of new anti-neoplastic therapy (efficacy follow-up period).&#xD;
&#xD;
      Subjects enter the survival follow-up period after completing the safety follow-up period or&#xD;
      experiencing disease progression as per RECIST 1.1 or response criteria for immunotherapy,&#xD;
      whichever period is longer (survival follow-up period).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 17, 2017</start_date>
  <completion_date type="Anticipated">December 29, 2023</completion_date>
  <primary_completion_date type="Actual">August 11, 2020</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Part 1 and Part 2 are open- label. Part 3 is double-blind and randomized.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)</measure>
    <time_frame>Up to 8 weeks (Part 1)</time_frame>
    <description>DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib</measure>
    <time_frame>Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days</time_frame>
    <description>Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib</measure>
    <time_frame>Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days</time_frame>
    <description>Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1</measure>
    <time_frame>Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)</time_frame>
    <description>Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to death due to any cause, assessed up to approximately 5 years</time_frame>
    <description>Overall survival is defined as the time from date of randomization to date of death due to any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1</measure>
    <time_frame>Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years</time_frame>
    <description>ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1</measure>
    <time_frame>From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)</time_frame>
    <description>DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1</measure>
    <time_frame>Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year</time_frame>
    <description>DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores</measure>
    <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
    <description>The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale.&#xD;
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.&#xD;
The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores</measure>
    <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
    <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The EORTC QLQ-C30 physical functioning scale measured a patient's ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1=&quot;not at all&quot; to 4=&quot;very much&quot;. The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning.&#xD;
The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores</measure>
    <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
    <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1=&quot;not at all&quot; to 4=&quot;very much&quot;. The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain.&#xD;
The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status</measure>
    <time_frame>From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)</time_frame>
    <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.&#xD;
The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score</measure>
    <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
    <description>The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma.&#xD;
The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= &quot;Not at all&quot;, 1= &quot;a little bit&quot;, 2= &quot;somewhat&quot;, 3= &quot;quite a bit&quot; and 4= &quot;very much&quot;. The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma.&#xD;
The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score</measure>
    <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
    <description>The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.&#xD;
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression</measure>
    <time_frame>Up to disease progression or death due to any cause, up to 2.8 years (Part 3)</time_frame>
    <description>PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.&#xD;
PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having &lt; 1% expression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Randomized (Part 3): OS by PD-L1 Expression</measure>
    <time_frame>Up to death due to any cause, up to 5 years</time_frame>
    <description>OS is defined as the time from date of randomization to date of death due to any cause.&#xD;
OS analysis will be performed by PD-L1 subgroup (positive, negative) where a positive status is defined as having ≥ 1% expression and a negative status is defined as having &lt; 1% expression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spartalizumab ADA Incidence</measure>
    <time_frame>Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).</time_frame>
    <description>Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough Concentration (Ctrough) for Spartalizumab</measure>
    <time_frame>Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days</time_frame>
    <description>Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-dose Plasma Concentration for Dabrafenib</measure>
    <time_frame>Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days</time_frame>
    <description>Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-dose Plasma Concentration for Trametinib</measure>
    <time_frame>Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days</time_frame>
    <description>Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Dose Interruptions</measure>
    <time_frame>From baseline to end of treatment, up to 5 years</time_frame>
    <description>Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Dose Reductions</measure>
    <time_frame>From baseline to end of treatment, up to 5 years</time_frame>
    <description>Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Dose Intensity</measure>
    <time_frame>From baseline to end of treatment, up to 5 years</time_frame>
    <description>Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio of dose intensity and planned dose intensity</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">568</enrollment>
  <condition>Melanoma</condition>
  <arm_group>
    <arm_group_label>Part 1: Safety run-in Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 1, participants are treated at different dose levels to determine the recommended Phase 3 regimen of spartalizumab in combination with dabrafenib and trametinib. The starting dose of spartalizumab is 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Biomarker cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Spartalizumab</intervention_name>
    <description>Spartalizumab powder for solution is used in Part 1 and Part 2, and as concentrate for solution for infusion for Part 3. Spartalizumab is administered via intravenous infusion over 30 minutes once every 4 weeks</description>
    <arm_group_label>Part 1: Safety run-in Cohort</arm_group_label>
    <arm_group_label>Part 2: Biomarker cohort</arm_group_label>
    <arm_group_label>Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib</arm_group_label>
    <other_name>PDR001</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo is administered via intravenous infusion over 30 minutes once every 4 weeks</description>
    <arm_group_label>Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabrafenib</intervention_name>
    <description>Dabrafenib 150 mg capsules BID is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions.</description>
    <arm_group_label>Part 1: Safety run-in Cohort</arm_group_label>
    <arm_group_label>Part 2: Biomarker cohort</arm_group_label>
    <arm_group_label>Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib</arm_group_label>
    <arm_group_label>Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trametinib</intervention_name>
    <description>Trametinib 2 mg tablets QD is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions</description>
    <arm_group_label>Part 1: Safety run-in Cohort</arm_group_label>
    <arm_group_label>Part 2: Biomarker cohort</arm_group_label>
    <arm_group_label>Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib</arm_group_label>
    <arm_group_label>Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria Part 1: Safety run-in&#xD;
&#xD;
          -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation&#xD;
&#xD;
          -  Aspartate transaminase (AST) &lt; 2.5× ULN and Alanine transaminase (ALT) &lt; 2.5× ULN&#xD;
&#xD;
          -  Measurable disease according to RECIST 1.1&#xD;
&#xD;
          -  ECOG performance status ≤ 1&#xD;
&#xD;
        Part 2: Biomarker cohort&#xD;
&#xD;
          -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation&#xD;
&#xD;
          -  At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection&#xD;
&#xD;
          -  Measurable disease according to RECIST 1.1&#xD;
&#xD;
          -  ECOG performance status ≤ 2&#xD;
&#xD;
        Part 3: Double-blind, randomized, placebo-controlled part&#xD;
&#xD;
          -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation&#xD;
&#xD;
          -  ECOG performance status ≤ 2&#xD;
&#xD;
          -  Measurable disease according to RECIST 1.1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Part 1: Safety run-in&#xD;
&#xD;
          -  Subjects with uveal or mucosal melanoma&#xD;
&#xD;
          -  Any history of CNS metastases&#xD;
&#xD;
          -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma&#xD;
&#xD;
          -  Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to&#xD;
             enrollmen&#xD;
&#xD;
          -  Radiation therapy within 4 weeks prior to start of study treatment&#xD;
&#xD;
          -  Active autoimmune disease, and/or history of autoimmune disease(s) that required&#xD;
             treatment&#xD;
&#xD;
        Parts 2 &amp; 3: Biomarker cohort &amp; double-blind, randomized, placebo-controlled part&#xD;
&#xD;
          -  Subjects with uveal or mucosal melanoma&#xD;
&#xD;
          -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma&#xD;
&#xD;
          -  Neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Radiation therapy within 4 weeks prior to start of study treatment&#xD;
&#xD;
          -  Clinically active cerebral melanoma metastasis.&#xD;
&#xD;
          -  Active autoimmune disease, and/or history of autoimmune disease(s) that required&#xD;
             treatment&#xD;
&#xD;
        Other protocol-defined Inclusion/Exclusion may 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>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California Cancer Associates for Research and Excellence SC-2</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>UC Irvine Medical Center SC</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>California Pacific Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Center SC-2</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center SC</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins U SC</name>
      <address>
        <city>Lutherville</city>
        <state>Maryland</state>
        <zip>21093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Cancer Specialists</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Laura and Isaac Perlmutter Cancer Center SC</name>
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        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center SC</name>
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        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center SC</name>
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        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
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  </location>
  <location>
    <facility>
      <name>University of TX MD Anderson Cancer Center SC-2</name>
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        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Buenos Aires</state>
        <zip>C1125ABD</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <zip>C1426ANZ</zip>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000KZE</zip>
        <country>Argentina</country>
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  </location>
  <location>
    <facility>
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      <address>
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        <zip>C1431FWO</zip>
        <country>Argentina</country>
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  <location>
    <facility>
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      <address>
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        <state>New South Wales</state>
        <zip>2290</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>North Sydney</city>
        <state>New South Wales</state>
        <zip>2060</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Greenslopes</city>
        <state>Queensland</state>
        <zip>4120</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Prahran</city>
        <state>Victoria</state>
        <zip>3181</zip>
        <country>Australia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Innsbruck</city>
        <state>Tyrol</state>
        <zip>6020</zip>
        <country>Austria</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Salzburg</city>
        <zip>A-5020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St Poelten</city>
        <zip>3100</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jette</city>
        <state>Brussel</state>
        <zip>1090</zip>
        <country>Belgium</country>
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    </facility>
  </location>
  <location>
    <facility>
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      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>80530 010</zip>
        <country>Brazil</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <state>RS</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
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  <location>
    <facility>
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        <state>SP</state>
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  <location>
    <facility>
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      <address>
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  <location>
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      <address>
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  <location>
    <facility>
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      <address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <state>British Columbia</state>
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  <location>
    <facility>
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        <country>Canada</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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      <address>
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        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <zip>J1H 5N4</zip>
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  </location>
  <location>
    <facility>
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      <address>
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        <state>Araucania</state>
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        <country>Chile</country>
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  <location>
    <facility>
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      <address>
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  </location>
  <location>
    <facility>
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      <address>
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        <country>Chile</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>Czech Republic</state>
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        <country>Czechia</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <state>CZE</state>
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        <country>Czechia</country>
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  <location>
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        <zip>779 00</zip>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
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      <address>
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  <location>
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        <zip>80054</zip>
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  <location>
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      <address>
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        <zip>25030</zip>
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  <location>
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      <address>
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        <zip>93009</zip>
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  <location>
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  <location>
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  <location>
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      <address>
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        <zip>14033</zip>
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  <location>
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        <zip>63003</zip>
        <country>France</country>
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  <location>
    <facility>
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        <zip>21000</zip>
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    </facility>
  </location>
  <location>
    <facility>
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      <address>
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        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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      <address>
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        <zip>59037</zip>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
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      <address>
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        <zip>56322</zip>
        <country>France</country>
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    </facility>
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  <location>
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        <zip>69373</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
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        <zip>13885</zip>
        <country>France</country>
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    </facility>
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  <location>
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    </facility>
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  <location>
    <facility>
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        <zip>06202</zip>
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      </address>
    </facility>
  </location>
  <location>
    <facility>
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      <address>
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        <zip>75475</zip>
        <country>France</country>
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    </facility>
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  <location>
    <facility>
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      <address>
        <city>Pierre Benite</city>
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  <location>
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        <zip>86021</zip>
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    </facility>
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  <location>
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  <location>
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    </facility>
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  <location>
    <facility>
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      <address>
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        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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      <address>
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        <zip>31059</zip>
        <country>France</country>
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    </facility>
  </location>
  <location>
    <facility>
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    </facility>
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  <location>
    <facility>
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    </facility>
  </location>
  <location>
    <facility>
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        <zip>68305</zip>
        <country>Germany</country>
      </address>
    </facility>
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  <location>
    <facility>
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      <address>
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        <state>Bavaria</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>13578</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
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        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
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        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
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      <address>
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        <zip>40225</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Erfurt</city>
        <zip>99089</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gera</city>
        <zip>07548</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Halle Saale</city>
        <zip>06120</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Homburg</city>
        <zip>66421</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Marburg</city>
        <zip>35039</zip>
        <country>Germany</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Minden</city>
        <zip>32429</zip>
        <country>Germany</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muenchen</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Muenster</city>
        <zip>48157</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Stade</city>
        <zip>21682</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Tuebingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Athens</city>
        <zip>115 27</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Athens</city>
        <zip>18547</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Budapest</city>
        <zip>H 1122</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Szeged</city>
        <zip>H 6725</zip>
        <country>Hungary</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>9112001</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ramat Gan</city>
        <zip>52621</zip>
        <country>Israel</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bari</city>
        <state>BA</state>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bergamo</city>
        <state>BG</state>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bologna</city>
        <state>BO</state>
        <zip>40138</zip>
        <country>Italy</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Brescia</city>
        <state>BS</state>
        <zip>25123</zip>
        <country>Italy</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Meldola</city>
        <state>FC</state>
        <zip>47014</zip>
        <country>Italy</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Genova</city>
        <state>GE</state>
        <zip>16132</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20900</zip>
        <country>Italy</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20133</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20141</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Modena</city>
        <state>MO</state>
        <zip>41124</zip>
        <country>Italy</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Padova</city>
        <state>PD</state>
        <zip>35100</zip>
        <country>Italy</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Roma</city>
        <state>RM</state>
        <zip>00167</zip>
        <country>Italy</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Siena</city>
        <state>SI</state>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Candiolo</city>
        <state>TO</state>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Torino</city>
        <state>TO</state>
        <zip>10126</zip>
        <country>Italy</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Verona</city>
        <state>VR</state>
        <zip>37126</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Kyushu University Hospital</name>
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        <city>Fukuoka city</city>
        <state>Fukuoka</state>
        <zip>812-8582</zip>
        <country>Japan</country>
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    </facility>
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  <location>
    <facility>
      <name>Kyoto University Hospital</name>
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        <city>Sakyo Ku</city>
        <state>Kyoto</state>
        <zip>606 8507</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
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        <city>Osaka-city</city>
        <state>Osaka</state>
        <zip>541-8567</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Tokyo Metropolitan Komagome Hospital</name>
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        <city>Bunkyo ku</city>
        <state>Tokyo</state>
        <zip>113-8677</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>National Cancer Hospital</name>
      <address>
        <city>Chuo ku</city>
        <state>Tokyo</state>
        <zip>104 0045</zip>
        <country>Japan</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>14080</zip>
        <country>Mexico</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leon</city>
        <state>Guanajuato</state>
        <zip>37178</zip>
        <country>Mexico</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44100</zip>
        <country>Mexico</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Breda</city>
        <zip>4819 EV</zip>
        <country>Netherlands</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leiden</city>
        <zip>2300 RC</zip>
        <country>Netherlands</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gdansk</city>
        <zip>80 952</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Warszawa</city>
        <zip>02 781</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1099 023</zip>
        <country>Portugal</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454048</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>143423</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603137</zip>
        <country>Russian Federation</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Omsk</city>
        <zip>644013</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>198255</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Samara</city>
        <zip>443011</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>St Petersburg</city>
        <zip>197758</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Malaga</city>
        <state>Andalucia</state>
        <zip>29010</zip>
        <country>Spain</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sevilla</city>
        <state>Andalucia</state>
        <zip>41009</zip>
        <country>Spain</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Oviedo</city>
        <state>Asturias</state>
        <zip>33011</zip>
        <country>Spain</country>
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    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jerez</city>
        <state>Cadiz</state>
        <zip>11407</zip>
        <country>Spain</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Badalona</city>
        <state>Catalunya</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Barcelona</city>
        <state>Catalunya</state>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Valencia</city>
        <state>Comunidad Valenciana</state>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>La Coruna</city>
        <state>Galicia</state>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Las Palmas De Gran Canarias</city>
        <state>Las Palmas De Gran Canaria</state>
        <zip>35016</zip>
        <country>Spain</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Goteborg</city>
        <zip>SE-413 45</zip>
        <country>Sweden</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lund</city>
        <zip>221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Stockholm</city>
        <zip>SE 171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Aarau</city>
        <zip>5001</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Zuerich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Songkhla</city>
        <state>Hat Yai</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangkok</city>
        <zip>10330</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Truro</city>
        <state>Cornwall</state>
        <zip>TR1 3LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Surrey</city>
        <state>England</state>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Northwood</city>
        <state>Middlesex</state>
        <zip>HA6 2RN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Sutton</city>
        <state>Surrey</state>
        <zip>SM2 5PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>London</city>
        <zip>NW3 2QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Preston</city>
        <zip>PR2 9HT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Switzerland</country>
    <country>Thailand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>June 26, 2023</results_first_submitted>
  <results_first_submitted_qc>June 26, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">July 24, 2023</results_first_posted>
  <disposition_first_submitted>July 5, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>July 5, 2021</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 8, 2021</disposition_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spartalizumab (PDR001)</keyword>
  <keyword>dabrafenib</keyword>
  <keyword>trametinib</keyword>
  <keyword>melanoma</keyword>
  <keyword>immunotherapy</keyword>
  <keyword>PD 1 inhibitor</keyword>
  <keyword>anti PD1</keyword>
  <keyword>PD-1</keyword>
  <keyword>anti-PD-1</keyword>
  <keyword>combination treatment</keyword>
  <keyword>malignant skin cancer</keyword>
  <keyword>skin cancer</keyword>
  <keyword>BRAF V600</keyword>
  <keyword>unresectable BRAF V600 mutated melanoma</keyword>
  <keyword>metastatic BRAF V600 mutated melanoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trametinib</mesh_term>
    <mesh_term>Dabrafenib</mesh_term>
    <mesh_term>Spartalizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 27, 2023</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02967692/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>July 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02967692/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Part 1 and 2 were conducted in 18 centers across 12 countries. Part 3 is conducted in 191 centers across 29 countries</recruitment_details>
      <pre_assignment_details>The screening phase began once written informed consent was provided and ended after 28 days or when subject received the first dose (Part 1 and 2) or was randomized (Part 3), whichever came first.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
          <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
        </group>
        <group group_id="P2">
          <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
          <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
        </group>
        <group group_id="P3">
          <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
          <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
        </group>
        <group group_id="P4">
          <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
          <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="267"/>
                <participants group_id="P4" count="265"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="267"/>
                <participants group_id="P4" count="264"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="267"/>
                <participants group_id="P4" count="265"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Treatment ongoing at the time of the data cut-off date of 01-Jul-2020</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="86"/>
                <participants group_id="P4" count="82"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="99"/>
                <participants group_id="P4" count="128"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject/guardian decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol deviation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </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="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="51"/>
                <participants group_id="P4" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
          <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
        </group>
        <group group_id="B2">
          <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
          <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
        </group>
        <group group_id="B3">
          <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
          <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
        </group>
        <group group_id="B4">
          <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
          <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
        </group>
        <group group_id="B5">
          <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="9"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="267"/>
            <count group_id="B4" value="265"/>
            <count group_id="B5" value="568"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="189"/>
                    <measurement group_id="B4" value="195"/>
                    <measurement group_id="B5" value="409"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="78"/>
                    <measurement group_id="B4" value="70"/>
                    <measurement group_id="B5" value="159"/>
                  </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="12"/>
                    <measurement group_id="B3" value="119"/>
                    <measurement group_id="B4" value="106"/>
                    <measurement group_id="B5" value="239"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="148"/>
                    <measurement group_id="B4" value="159"/>
                    <measurement group_id="B5" value="329"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="225"/>
                    <measurement group_id="B4" value="227"/>
                    <measurement group_id="B5" value="485"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)</title>
        <description>DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs</description>
        <time_frame>Up to 8 weeks (Part 1)</time_frame>
        <population>Dose-Determining Set (DDS) including all subjects in Part 1 who received at least one dose of study treatment who either 1) met the minimum exposure criterion and had sufficient safety evaluations, or 2) experienced a DLT during the first 8 weeks (56 days) of spartalizumab in combination with dabrafenib and trametinib dosing.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)</title>
          <description>DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs</description>
          <population>Dose-Determining Set (DDS) including all subjects in Part 1 who received at least one dose of study treatment who either 1) met the minimum exposure criterion and had sufficient safety evaluations, or 2) experienced a DLT during the first 8 weeks (56 days) of spartalizumab in combination with dabrafenib and trametinib dosing.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib</title>
        <description>Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2</description>
        <time_frame>Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days</time_frame>
        <population>Participants in Part 2 who received at least one dose of study treatment and with evaluable data at the pre-specified time points</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
        </group_list>
        <measure>
          <title>Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib</title>
          <description>Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2</description>
          <population>Participants in Part 2 who received at least one dose of study treatment and with evaluable data at the pre-specified time points</population>
          <units>Percentage of positive tumor cells</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </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="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="13.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="7.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib</title>
        <description>Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2</description>
        <time_frame>Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days</time_frame>
        <population>Participants in Part 2 who received at least one dose of study treatment and with evaluable data at the pre-specified time points</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
        </group_list>
        <measure>
          <title>Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib</title>
          <description>Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2</description>
          <population>Participants in Part 2 who received at least one dose of study treatment and with evaluable data at the pre-specified time points</population>
          <units>Percentage Marker Area</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </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="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="3.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="2.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1</title>
        <description>Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.</description>
        <time_frame>Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)</time_frame>
        <population>All participants in Part 3 to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1</title>
          <description>Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.</description>
          <population>All participants in Part 3 to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="267"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" lower_limit="12.7" upper_limit="23.9"/>
                    <measurement group_id="O2" value="12.0" lower_limit="10.2" upper_limit="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.042</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.820</param_value>
            <ci_percent>2</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.655</ci_lower_limit>
            <ci_upper_limit>1.027</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival is defined as the time from date of randomization to date of death due to any cause</description>
        <time_frame>Up to death due to any cause, assessed up to approximately 5 years</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1</title>
        <description>ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters</description>
        <time_frame>Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years</time_frame>
        <population>For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment.&#xD;
For Part 3: all subjects to whom study treatment was assigned by randomization, regardless of whether or not treatment was administered.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O2">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O3">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O4">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1</title>
          <description>ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters</description>
          <population>For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment.&#xD;
For Part 3: all subjects to whom study treatment was assigned by randomization, regardless of whether or not treatment was administered.</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="9"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="267"/>
                <count group_id="O4" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="66.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="70.4" lower_limit="49.8" upper_limit="86.2"/>
                    <measurement group_id="O3" value="68.5" lower_limit="62.6" upper_limit="74.1"/>
                    <measurement group_id="O4" value="64.2" lower_limit="58.1" upper_limit="69.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1</title>
        <description>DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters</description>
        <time_frame>From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)</time_frame>
        <population>For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment for whom best overall response was CR or PR.&#xD;
For Part 3: all subjects to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) for whom best overall response was CR or PR.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O2">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O3">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O4">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1</title>
          <description>DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters</description>
          <population>For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment for whom best overall response was CR or PR.&#xD;
For Part 3: all subjects to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) for whom best overall response was CR or PR.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="19"/>
                <count group_id="O3" value="183"/>
                <count group_id="O4" value="170"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="8.3" upper_limit="NA">Not estimable (NA) due to the insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="20.0" lower_limit="9.4" upper_limit="NA">Not estimable (NA) due to the insufficient number of participants with events</measurement>
                    <measurement group_id="O3" value="NA" lower_limit="18.6" upper_limit="NA">Not estimable (NA) due to the insufficient number of participants with events</measurement>
                    <measurement group_id="O4" value="20.7" lower_limit="13.0" upper_limit="NA">Not estimable (NA) due to the insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1</title>
        <description>DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.</description>
        <time_frame>Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year</time_frame>
        <population>For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment.&#xD;
For Part 3: all subjects to whom study treatment was assigned by randomization, regardless of whether or not treatment was administered.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O2">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O3">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O4">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1</title>
          <description>DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria.&#xD;
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to &lt;10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.</description>
          <population>For Part 1 and 2: all subjects to whom study treatment was assigned and who received at least one dose of any study treatment.&#xD;
For Part 3: all subjects to whom study treatment was assigned by randomization, regardless of whether or not treatment was administered.</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="9"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="267"/>
                <count group_id="O4" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="66.4" upper_limit="100.0"/>
                    <measurement group_id="O2" value="92.6" lower_limit="75.7" upper_limit="99.1"/>
                    <measurement group_id="O3" value="84.3" lower_limit="79.3" upper_limit="88.4"/>
                    <measurement group_id="O4" value="86.4" lower_limit="81.7" upper_limit="90.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores</title>
        <description>The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale.&#xD;
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.&#xD;
The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.</description>
        <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
        <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores</title>
          <description>The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale.&#xD;
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.&#xD;
The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.</description>
          <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                    <count group_id="O2" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.81" spread="19.300"/>
                    <measurement group_id="O2" value="2.20" spread="24.918"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="25.050"/>
                    <measurement group_id="O2" value="1.90" spread="21.197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="24.526"/>
                    <measurement group_id="O2" value="0.50" spread="19.608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.88" spread="23.088"/>
                    <measurement group_id="O2" value="0.27" spread="18.752"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="25.906"/>
                    <measurement group_id="O2" value="0.00" spread="24.541"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 14 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.65" spread="23.561"/>
                    <measurement group_id="O2" value="-0.89" spread="23.306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.82" spread="25.186"/>
                    <measurement group_id="O2" value="1.76" spread="24.142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 18 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.46" spread="24.106"/>
                    <measurement group_id="O2" value="-0.10" spread="19.193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" spread="21.766"/>
                    <measurement group_id="O2" value="-1.02" spread="23.144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 22 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.95" spread="22.047"/>
                    <measurement group_id="O2" value="2.29" spread="21.947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 25 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.57" spread="23.981"/>
                    <measurement group_id="O2" value="-0.24" spread="25.497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 28 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.50" spread="19.793"/>
                    <measurement group_id="O2" value="1.06" spread="22.513"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 31 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.59" spread="24.967"/>
                    <measurement group_id="O2" value="6.73" spread="21.084"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 34 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.67" spread="47.140"/>
                    <measurement group_id="O2" value="13.89" spread="20.184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.59" spread="24.967"/>
                    <measurement group_id="O2" value="-7.78" spread="29.274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.54" spread="16.506"/>
                    <measurement group_id="O2" value="-17.19" spread="24.050"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores</title>
        <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The EORTC QLQ-C30 physical functioning scale measured a patient's ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1=&quot;not at all&quot; to 4=&quot;very much&quot;. The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning.&#xD;
The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.</description>
        <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
        <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores</title>
          <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The EORTC QLQ-C30 physical functioning scale measured a patient's ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1=&quot;not at all&quot; to 4=&quot;very much&quot;. The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning.&#xD;
The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.</description>
          <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                    <count group_id="O2" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.52" spread="16.243"/>
                    <measurement group_id="O2" value="-0.70" spread="17.618"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                    <count group_id="O2" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.38" spread="16.121"/>
                    <measurement group_id="O2" value="-0.60" spread="14.824"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.29" spread="18.350"/>
                    <measurement group_id="O2" value="-0.59" spread="15.687"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.18" spread="17.985"/>
                    <measurement group_id="O2" value="-1.11" spread="13.736"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.39" spread="18.108"/>
                    <measurement group_id="O2" value="-0.85" spread="10.652"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 14 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.42" spread="16.720"/>
                    <measurement group_id="O2" value="-2.61" spread="12.320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.19" spread="20.301"/>
                    <measurement group_id="O2" value="-2.24" spread="13.331"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 18 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.48" spread="18.862"/>
                    <measurement group_id="O2" value="-3.55" spread="13.474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.07" spread="15.316"/>
                    <measurement group_id="O2" value="-1.73" spread="11.536"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 22 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.21" spread="15.538"/>
                    <measurement group_id="O2" value="-0.85" spread="11.157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 25 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.35" spread="16.510"/>
                    <measurement group_id="O2" value="-2.67" spread="13.158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 28 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.80" spread="13.843"/>
                    <measurement group_id="O2" value="-2.67" spread="15.953"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 31 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.03" spread="10.719"/>
                    <measurement group_id="O2" value="-1.79" spread="9.533"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 34 Day 1</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_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.00" spread="0.000"/>
                    <measurement group_id="O2" value="-3.33" spread="5.578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.67" spread="18.641"/>
                    <measurement group_id="O2" value="-8.67" spread="19.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.85" spread="15.977"/>
                    <measurement group_id="O2" value="-21.25" spread="27.991"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores</title>
        <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1=&quot;not at all&quot; to 4=&quot;very much&quot;. The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain.&#xD;
The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.</description>
        <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
        <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores</title>
          <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1=&quot;not at all&quot; to 4=&quot;very much&quot;. The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain.&#xD;
The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.</description>
          <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="175"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="175"/>
                    <count group_id="O2" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.24" spread="26.434"/>
                    <measurement group_id="O2" value="-5.29" spread="24.881"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                    <count group_id="O2" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.43" spread="28.820"/>
                    <measurement group_id="O2" value="-7.49" spread="23.611"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="146"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.91" spread="29.176"/>
                    <measurement group_id="O2" value="-4.11" spread="24.420"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.95" spread="28.346"/>
                    <measurement group_id="O2" value="-4.76" spread="23.557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.33" spread="28.890"/>
                    <measurement group_id="O2" value="-5.26" spread="22.646"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 14 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="103"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.50" spread="28.140"/>
                    <measurement group_id="O2" value="-3.56" spread="23.062"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.86" spread="26.220"/>
                    <measurement group_id="O2" value="-4.44" spread="25.820"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 18 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.15" spread="30.178"/>
                    <measurement group_id="O2" value="-3.21" spread="20.898"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.47" spread="30.659"/>
                    <measurement group_id="O2" value="-2.85" spread="23.249"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 22 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.49" spread="27.049"/>
                    <measurement group_id="O2" value="-3.54" spread="23.969"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 25 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.25" spread="28.868"/>
                    <measurement group_id="O2" value="-4.76" spread="20.685"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 28 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.00" spread="26.872"/>
                    <measurement group_id="O2" value="-3.03" spread="22.701"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 31 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.14" spread="24.995"/>
                    <measurement group_id="O2" value="-7.05" spread="34.696"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 34 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.33" spread="11.785"/>
                    <measurement group_id="O2" value="-5.56" spread="8.607"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.42" spread="28.791"/>
                    <measurement group_id="O2" value="0.56" spread="28.190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.38" spread="19.792"/>
                    <measurement group_id="O2" value="11.46" spread="24.884"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status</title>
        <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.&#xD;
The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.</description>
        <time_frame>From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)</time_frame>
        <population>All participants in Part 3 to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status</title>
          <description>The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.&#xD;
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.&#xD;
The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.</description>
          <population>All participants in Part 3 to whom study treatment was assigned by randomization regardless of whether or not treatment was administered.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="267"/>
                <count group_id="O2" value="265"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="15.7" upper_limit="24.9"/>
                    <measurement group_id="O2" value="22.1" lower_limit="17.5" upper_limit="NA">Not estimable (NA) due to the insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2975</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.183</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.865</ci_lower_limit>
            <ci_upper_limit>1.619</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score</title>
        <description>The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma.&#xD;
The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= &quot;Not at all&quot;, 1= &quot;a little bit&quot;, 2= &quot;somewhat&quot;, 3= &quot;quite a bit&quot; and 4= &quot;very much&quot;. The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma.&#xD;
The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.</description>
        <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
        <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score</title>
          <description>The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma.&#xD;
The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= &quot;Not at all&quot;, 1= &quot;a little bit&quot;, 2= &quot;somewhat&quot;, 3= &quot;quite a bit&quot; and 4= &quot;very much&quot;. The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma.&#xD;
The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.</description>
          <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" spread="6.600"/>
                    <measurement group_id="O2" value="0.87" spread="6.185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" spread="7.370"/>
                    <measurement group_id="O2" value="1.18" spread="6.219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="150"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.14" spread="7.284"/>
                    <measurement group_id="O2" value="1.09" spread="5.742"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="133"/>
                    <count group_id="O2" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.52" spread="7.314"/>
                    <measurement group_id="O2" value="0.54" spread="6.492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="112"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.21" spread="7.515"/>
                    <measurement group_id="O2" value="0.47" spread="5.974"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 14 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.77" spread="7.071"/>
                    <measurement group_id="O2" value="0.65" spread="6.681"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="90"/>
                    <count group_id="O2" value="92"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" spread="6.451"/>
                    <measurement group_id="O2" value="0.71" spread="6.374"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 18 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.23" spread="7.095"/>
                    <measurement group_id="O2" value="0.47" spread="6.152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="6.634"/>
                    <measurement group_id="O2" value="0.53" spread="5.875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 22 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.87" spread="6.215"/>
                    <measurement group_id="O2" value="0.79" spread="5.970"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 25 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="70"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" spread="5.950"/>
                    <measurement group_id="O2" value="0.74" spread="6.792"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 28 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="50"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" spread="5.195"/>
                    <measurement group_id="O2" value="0.61" spread="8.020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 31 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="5.702"/>
                    <measurement group_id="O2" value="1.88" spread="6.154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 34 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.50" spread="2.121"/>
                    <measurement group_id="O2" value="4.60" spread="3.578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="7.620"/>
                    <measurement group_id="O2" value="-1.07" spread="8.590"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.60" spread="5.734"/>
                    <measurement group_id="O2" value="-3.06" spread="8.948"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score</title>
        <description>The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.&#xD;
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.</description>
        <time_frame>From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)</time_frame>
        <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score</title>
          <description>The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.&#xD;
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.</description>
          <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) and with available data at the pre-specified time points</population>
          <units>Score on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="176"/>
                <count group_id="O2" value="190"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 4 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="190"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="16.567"/>
                    <measurement group_id="O2" value="2.16" spread="19.733"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="156"/>
                    <count group_id="O2" value="158"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.55" spread="20.751"/>
                    <measurement group_id="O2" value="3.10" spread="16.095"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="145"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="20.246"/>
                    <measurement group_id="O2" value="2.60" spread="15.200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="124"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.45" spread="19.050"/>
                    <measurement group_id="O2" value="2.52" spread="16.144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="110"/>
                    <count group_id="O2" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.88" spread="24.653"/>
                    <measurement group_id="O2" value="1.42" spread="15.695"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 14 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.62" spread="19.455"/>
                    <measurement group_id="O2" value="1.71" spread="14.337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 16 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="89"/>
                    <count group_id="O2" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.30" spread="18.640"/>
                    <measurement group_id="O2" value="2.79" spread="16.996"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 18 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="88"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.16" spread="20.762"/>
                    <measurement group_id="O2" value="1.91" spread="16.743"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 20 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.34" spread="17.831"/>
                    <measurement group_id="O2" value="1.28" spread="16.108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 22 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="80"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.01" spread="19.102"/>
                    <measurement group_id="O2" value="1.55" spread="14.973"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 25 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="64"/>
                    <count group_id="O2" value="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.47" spread="19.489"/>
                    <measurement group_id="O2" value="0.26" spread="14.784"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 28 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="49"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.20" spread="17.545"/>
                    <measurement group_id="O2" value="-0.39" spread="18.529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 31 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="19.561"/>
                    <measurement group_id="O2" value="-0.08" spread="16.747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 34 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.50" spread="14.849"/>
                    <measurement group_id="O2" value="5.60" spread="19.008"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.04" spread="22.033"/>
                    <measurement group_id="O2" value="-10.24" spread="23.532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>60 days post-progression</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.25" spread="19.923"/>
                    <measurement group_id="O2" value="-8.19" spread="21.192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression</title>
        <description>PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.&#xD;
PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having &lt; 1% expression.</description>
        <time_frame>Up to disease progression or death due to any cause, up to 2.8 years (Part 3)</time_frame>
        <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) with an evaluable PD-L1 assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O2">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression</title>
          <description>PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.&#xD;
PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having &lt; 1% expression.</description>
          <population>All participants in Part 3 to whom study treatment was assigned by randomization (regardless of whether or not treatment was administered) with an evaluable PD-L1 assessment.</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="236"/>
                <count group_id="O2" value="241"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PD-L1 negative (&lt;1%)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="98"/>
                    <count group_id="O2" value="115"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="10.1" upper_limit="15.7"/>
                    <measurement group_id="O2" value="10.3" lower_limit="7.5" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PD-L1 positive (&gt;=1%)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="138"/>
                    <count group_id="O2" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" lower_limit="17.4" upper_limit="NA">Not estimable (NA) due to the insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="15.4" lower_limit="10.2" upper_limit="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Randomized (Part 3): OS by PD-L1 Expression</title>
        <description>OS is defined as the time from date of randomization to date of death due to any cause.&#xD;
OS analysis will be performed by PD-L1 subgroup (positive, negative) where a positive status is defined as having ≥ 1% expression and a negative status is defined as having &lt; 1% expression.</description>
        <time_frame>Up to death due to any cause, up to 5 years</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline</title>
        <description>Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.</description>
        <time_frame>Baseline</time_frame>
        <population>Part 1 and 2: All subjects to whom study treatment was assigned and who received any study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Part 3: All subjects randomized to spartalizumab with dabrafenib and trametinib with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Determinant sample: sample that is neither ADA-inconclusive nor unevaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O2">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O3">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline</title>
          <description>Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.</description>
          <population>Part 1 and 2: All subjects to whom study treatment was assigned and who received any study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Part 3: All subjects randomized to spartalizumab with dabrafenib and trametinib with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Determinant sample: sample that is neither ADA-inconclusive nor unevaluable</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="9"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="244"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Spartalizumab ADA Incidence</title>
        <description>Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)</description>
        <time_frame>Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).</time_frame>
        <population>Part 1 and 2: All subjects to whom study treatment was assigned and who received any study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Part 3: All subjects randomized to spartalizumab with dabrafenib and trametinib with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Determinant sample: sample that is neither ADA-inconclusive nor unevaluable</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O2">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O3">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Spartalizumab ADA Incidence</title>
          <description>Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)</description>
          <population>Part 1 and 2: All subjects to whom study treatment was assigned and who received any study treatment with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Part 3: All subjects randomized to spartalizumab with dabrafenib and trametinib with a determinant baseline immunogenicity sample and at least one determinant post-baseline immunogenicity sample. Determinant sample: sample that is neither ADA-inconclusive nor unevaluable</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="9"/>
                <count group_id="O2" value="26"/>
                <count group_id="O3" value="244"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Trough Concentration (Ctrough) for Spartalizumab</title>
        <description>Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.</description>
        <time_frame>Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days</time_frame>
        <population>All subjects who provided at least one evaluable spartalizumab PK concentration at the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O2">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O3">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Trough Concentration (Ctrough) for Spartalizumab</title>
          <description>Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.</description>
          <population>All subjects who provided at least one evaluable spartalizumab PK concentration at the specified time points.</population>
          <units>microgram (μg)/miliLiter (mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" spread="4.59"/>
                    <measurement group_id="O2" value="31.5" spread="20.3"/>
                    <measurement group_id="O3" value="28.4" spread="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="129"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.1" spread="7.07"/>
                    <measurement group_id="O2" value="56.1" spread="34.2"/>
                    <measurement group_id="O3" value="43.5" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="121"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8"/>
                    <measurement group_id="O2" value="46.9" spread="18.8"/>
                    <measurement group_id="O3" value="50.5" spread="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="126"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.3"/>
                    <measurement group_id="O2" value="56.7" spread="19.5"/>
                    <measurement group_id="O3" value="56.4" spread="24.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8" spread="16.9"/>
                    <measurement group_id="O2" value="60.9" spread="23.6"/>
                    <measurement group_id="O3" value="58.8" spread="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="119"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.1" spread="12.1"/>
                    <measurement group_id="O2" value="62.2" spread="33.3"/>
                    <measurement group_id="O3" value="63.7" spread="29.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.9" spread="12.7"/>
                    <measurement group_id="O2" value="65.8" spread="32.8"/>
                    <measurement group_id="O3" value="64.1" spread="29.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.2" spread="30.9"/>
                    <measurement group_id="O2" value="69.5" spread="25.2"/>
                    <measurement group_id="O3" value="67.8" spread="33.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.1" spread="22.5"/>
                    <measurement group_id="O2" value="68.4" spread="33.2"/>
                    <measurement group_id="O3" value="63.8" spread="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="91"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.9" spread="15.8"/>
                    <measurement group_id="O2" value="63.2" spread="35.8"/>
                    <measurement group_id="O3" value="62.1" spread="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.0" spread="16.5"/>
                    <measurement group_id="O2" value="61.6" spread="29.3"/>
                    <measurement group_id="O3" value="60.7" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pre-dose Plasma Concentration for Dabrafenib</title>
        <description>Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.</description>
        <time_frame>Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days</time_frame>
        <population>All subjects who provided at least one evaluable dabrafenib PK concentration at the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O2">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O3">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O4">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-dose Plasma Concentration for Dabrafenib</title>
          <description>Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.</description>
          <population>All subjects who provided at least one evaluable dabrafenib PK concentration at the specified time points.</population>
          <units>nanogram (ng)/ miliLiter (mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="18"/>
                <count group_id="O3" value="127"/>
                <count group_id="O4" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <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="18"/>
                    <count group_id="O3" value="125"/>
                    <count group_id="O4" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.7" spread="27.4"/>
                    <measurement group_id="O2" value="149" spread="391"/>
                    <measurement group_id="O3" value="208" spread="473"/>
                    <measurement group_id="O4" value="234" spread="475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</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="127"/>
                    <count group_id="O4" value="145"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" spread="10.4"/>
                    <measurement group_id="O2" value="183" spread="469"/>
                    <measurement group_id="O3" value="192" spread="607"/>
                    <measurement group_id="O4" value="135" spread="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4</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="116"/>
                    <count group_id="O4" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" spread="15.8"/>
                    <measurement group_id="O2" value="372" spread="811"/>
                    <measurement group_id="O3" value="169" spread="404"/>
                    <measurement group_id="O4" value="167" spread="328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="110"/>
                    <count group_id="O4" value="125"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.8" spread="30.6"/>
                    <measurement group_id="O2" value="152" spread="293"/>
                    <measurement group_id="O3" value="130" spread="317"/>
                    <measurement group_id="O4" value="152" spread="363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="110"/>
                    <count group_id="O4" value="113"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" spread="16.3"/>
                    <measurement group_id="O2" value="73.7" spread="131"/>
                    <measurement group_id="O3" value="198" spread="521"/>
                    <measurement group_id="O4" value="94.6" spread="186"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="111"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" spread="13.9"/>
                    <measurement group_id="O2" value="40.0" spread="20.0"/>
                    <measurement group_id="O3" value="180" spread="510"/>
                    <measurement group_id="O4" value="121" spread="279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="97"/>
                    <count group_id="O4" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="16.8"/>
                    <measurement group_id="O2" value="28.0" spread="10.4"/>
                    <measurement group_id="O3" value="173" spread="532"/>
                    <measurement group_id="O4" value="97.2" spread="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 9</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="91"/>
                    <count group_id="O4" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.3" spread="7.59"/>
                    <measurement group_id="O2" value="43.3" spread="40.6"/>
                    <measurement group_id="O3" value="143" spread="394"/>
                    <measurement group_id="O4" value="133" spread="259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="81"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" spread="9.19"/>
                    <measurement group_id="O2" value="60.0" spread="28.3"/>
                    <measurement group_id="O3" value="167" spread="472"/>
                    <measurement group_id="O4" value="122" spread="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11</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="79"/>
                    <count group_id="O4" value="77"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154" spread="250"/>
                    <measurement group_id="O2" value="33.8" spread="22.6"/>
                    <measurement group_id="O3" value="174" spread="667"/>
                    <measurement group_id="O4" value="119" spread="238"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="75"/>
                    <count group_id="O4" value="67"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="10.3"/>
                    <measurement group_id="O2" value="41.3" spread="37.2"/>
                    <measurement group_id="O3" value="148" spread="396"/>
                    <measurement group_id="O4" value="146" spread="295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 18</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 group_id="O3" value="24"/>
                    <count group_id="O4" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0"/>
                    <measurement group_id="O2" value="50.6" spread="49.7"/>
                    <measurement group_id="O3" value="180" spread="618"/>
                    <measurement group_id="O4" value="167" spread="385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 24</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 group_id="O3" value="19"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="91.5" spread="98.3"/>
                    <measurement group_id="O3" value="147" spread="344"/>
                    <measurement group_id="O4" value="60.2" spread="67.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.2"/>
                    <measurement group_id="O3" value="226" spread="488"/>
                    <measurement group_id="O4" value="47.6" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pre-dose Plasma Concentration for Trametinib</title>
        <description>Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.</description>
        <time_frame>Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days</time_frame>
        <population>All subjects who provided at least one evaluable trametinib PK concentration at the specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1- Safety run-in: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 1, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O2">
            <title>Part 2- Biomarker Cohort: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).</description>
          </group>
          <group group_id="O3">
            <title>Part 3- Arm 1: Spartalizumab 400 mg Q4W + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
          <group group_id="O4">
            <title>Part 3- Arm 2: Placebo + Dabrafenib 150 mg BID + Trametinib 2 mg QD</title>
            <description>In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-dose Plasma Concentration for Trametinib</title>
          <description>Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.</description>
          <population>All subjects who provided at least one evaluable trametinib PK concentration at the specified time points.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="103"/>
                <count group_id="O4" value="143"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <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="14"/>
                    <count group_id="O3" value="103"/>
                    <count group_id="O4" value="143"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="4.09"/>
                    <measurement group_id="O2" value="11.2" spread="3.4"/>
                    <measurement group_id="O3" value="11.5" spread="4.73"/>
                    <measurement group_id="O4" value="13.9" spread="9.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="131"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.34" spread="0.354"/>
                    <measurement group_id="O2" value="12.2" spread="2.55"/>
                    <measurement group_id="O3" value="11.4" spread="5.98"/>
                    <measurement group_id="O4" value="12.3" spread="5.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="102"/>
                    <count group_id="O4" value="117"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" spread="1.64"/>
                    <measurement group_id="O2" value="12.5" spread="4.84"/>
                    <measurement group_id="O3" value="11.7" spread="4.62"/>
                    <measurement group_id="O4" value="11.9" spread="5.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="100"/>
                    <count group_id="O4" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                    <measurement group_id="O2" value="12.6" spread="5.03"/>
                    <measurement group_id="O3" value="11.3" spread="4.91"/>
                    <measurement group_id="O4" value="11.6" spread="4.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="99"/>
                    <count group_id="O4" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" spread="1.38"/>
                    <measurement group_id="O2" value="11.8" spread="3.73"/>
                    <measurement group_id="O3" value="11.6" spread="5.12"/>
                    <measurement group_id="O4" value="10.9" spread="3.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="95"/>
                    <count group_id="O4" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="3.8"/>
                    <measurement group_id="O2" value="11.8" spread="5.24"/>
                    <measurement group_id="O3" value="12.0" spread="4.86"/>
                    <measurement group_id="O4" value="11.0" spread="4.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="87"/>
                    <count group_id="O4" value="94"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.24" spread="3.06"/>
                    <measurement group_id="O2" value="10.2" spread="4.13"/>
                    <measurement group_id="O3" value="10.3" spread="3.92"/>
                    <measurement group_id="O4" value="11.3" spread="4.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 9</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="78"/>
                    <count group_id="O4" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.73" spread="3.35"/>
                    <measurement group_id="O2" value="10.5" spread="4.43"/>
                    <measurement group_id="O3" value="10.9" spread="4.57"/>
                    <measurement group_id="O4" value="11.6" spread="4.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 10</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 group_id="O3" value="71"/>
                    <count group_id="O4" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.24"/>
                    <measurement group_id="O2" value="10.5" spread="4.02"/>
                    <measurement group_id="O3" value="10.9" spread="4.47"/>
                    <measurement group_id="O4" value="11.8" spread="4.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="71"/>
                    <count group_id="O4" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7"/>
                    <measurement group_id="O2" value="11.6" spread="4.69"/>
                    <measurement group_id="O3" value="10.3" spread="3.67"/>
                    <measurement group_id="O4" value="11.4" spread="3.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="65"/>
                    <count group_id="O4" value="65"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="3.92"/>
                    <measurement group_id="O2" value="11.0" spread="4.53"/>
                    <measurement group_id="O3" value="10.6" spread="4.31"/>
                    <measurement group_id="O4" value="11.2" spread="3.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 18</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 group_id="O3" value="25"/>
                    <count group_id="O4" value="21"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1"/>
                    <measurement group_id="O2" value="13.0" spread="4.6"/>
                    <measurement group_id="O3" value="9.66" spread="3.49"/>
                    <measurement group_id="O4" value="12.1" spread="5.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 24</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 group_id="O3" value="17"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="13.4" spread="8.03"/>
                    <measurement group_id="O3" value="10.7" spread="4.89"/>
                    <measurement group_id="O4" value="10.7" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.8"/>
                    <measurement group_id="O3" value="9.34" spread="7.56"/>
                    <measurement group_id="O4" value="10.1" spread="2.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 36</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Dose Interruptions</title>
        <description>Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib</description>
        <time_frame>From baseline to end of treatment, up to 5 years</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Dose Reductions</title>
        <description>Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib</description>
        <time_frame>From baseline to end of treatment, up to 5 years</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Dose Intensity</title>
        <description>Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio of dose intensity and planned dose intensity</description>
        <time_frame>From baseline to end of treatment, up to 5 years</time_frame>
        <posting_date>12/2024</posting_date>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment-emergent Adverse events were collected from first dose of study treatment to 150 days after last dose of study medication (on-treatment and post-treatment safety follow-up [FU]), up to 3.3 years (Part 1), 2.9 years (Part 2) and 2.8 years (Part 3). All-cause Mortality was collected from day of subject's informed consent until end of study, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).</time_frame>
      <desc>Treatment-emergent Adverse Events: Any sign or symptom that occured during the study treatment plus 30 days post treatment in the Safety Set (treated patients only). All-Cause Mortality is using the Full Analysis Set, including all participants to whom study treatment was assigned by randomization (Part 3) and all participants to whom study treatment was assigned and who received at least one one of any study treatment (Part 1 and 2)</desc>
      <group_list>
        <group group_id="E1">
          <title>All Participants (Pre-treatment)</title>
          <description>Deaths were collected in the pre-treatment period (from day of patient's informed consent to the day before first administration of study treatment )</description>
        </group>
        <group group_id="E2">
          <title>Part 1: Safety run-in Cohort (On-treatment and Post-treatment Safety FU)</title>
          <description>AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)</description>
        </group>
        <group group_id="E3">
          <title>Part 1: Safety run-in Cohort (Post-treatment Survival FU)</title>
          <description>Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period</description>
        </group>
        <group group_id="E4">
          <title>Part 2: Biomarker Cohort (On-treatment and Post-treatment Safety FU)</title>
          <description>AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)</description>
        </group>
        <group group_id="E5">
          <title>Part 2: Biomarker Cohort (Post-treatment Survival FU)</title>
          <description>Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period</description>
        </group>
        <group group_id="E6">
          <title>Part 3- Arm 1: Spartalizumab + Dabrafenib + Trametinib (On-treatment and Post-treatment Safety FU)</title>
          <description>AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)</description>
        </group>
        <group group_id="E7">
          <title>Part 3- Arm 1: Spartalizumab + Dabrafenib +Trametinib (Post-treatment Survival FU)</title>
          <description>Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period</description>
        </group>
        <group group_id="E8">
          <title>Part 3- Arm 2: Placebo + Dabrafenib + Trametinib (On-treatment and Post-treatment Safety FU)</title>
          <description>AEs during on-treatment period and post-treatment safety follow-up (up to 150 days post-treatment)</description>
        </group>
        <group group_id="E9">
          <title>Part 3- Arm 2: Placebo + Dabrafenib + Trametinib (Post-treatment Survival FU)</title>
          <description>Deaths collected in the post-treatment survival follow-up period (starting from day 151 post- treatment). No AEs were collected during this period</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (22.0)</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="1" subjects_at_risk="568"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E6" subjects_affected="45" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_affected="45" subjects_at_risk="122"/>
                <counts group_id="E8" subjects_affected="64" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_affected="38" subjects_at_risk="139"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="140" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="112" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Left ventricular dysfunction</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Angle closure glaucoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Detachment of retinal pigment epithelium</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Iridocyclitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Macular detachment</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Abdominal wall haematoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Administration site extravasation</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="46" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ulcer</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatic failure</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Portal vein thrombosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Haemophagocytic lymphohistiocytosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Bacterial food poisoning</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sweating fever</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urinary tract infection fungal</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Post embolisation syndrome</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Scapula fracture</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Wound haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Chest X-ray abnormal</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>General physical condition abnormal</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Streptococcus test positive</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Muscle haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Soft tissue necrosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma pancreas</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Intracranial tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Metastasis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's lymphoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Oncologic complication</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urinary tract neoplasm</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Uterine neoplasm</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Brain oedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Immune-mediated encephalitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Meningism</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Monoparesis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Neuritis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Neurological decompensation</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Peripheral motor neuropathy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Nephritis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Tubulointerstitial nephritis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urethral stenosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatic disorder</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune lung disease</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative generalised</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Peau d'orange</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pemphigoid</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hipersensitivity vasculitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aneurysm ruptured</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (22.0)</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="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="27" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="264" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="251" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="44" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="29" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="39" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="31" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="20" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear congestion</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Motion sickness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="17" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Thyroiditis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Iridocyclitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ocular discomfort</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Papilloedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Periorbital oedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Retinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Retinopathy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Vitreal cells</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="23" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="22" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="15" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="37" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="37" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="93" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="67" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="21" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="13" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Glossitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="84" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="72" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Trichoglossia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="62" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="47" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="68" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="52" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="82" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="62" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="69" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="68" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="27" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="15" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Oedema due to cardiac disease</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="27" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="23" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="186" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="137" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune hepatitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="23" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="26" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Otitis media chronic</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="26" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="18" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Viral rhinitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Compression fracture</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Radiation skin injury</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="62" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="40" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="40" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="71" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="49" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="29" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="26" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="9" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="69" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="70" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="22" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="21" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood testosterone decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="20" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="20" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Globulins increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="61" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="33" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Myoglobin blood increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="32" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="26" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="33" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="74" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="68" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="32" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="32" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Limb discomfort</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="27" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="20" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="15" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="14" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="39" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="33" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Osteopenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="22" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Fibrous histiocytoma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Anosmia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="18" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="21" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="77" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="69" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="14" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Peroneal nerve palsy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bradyphrenia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Disorientation</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="17" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="58" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="40" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="32" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="29" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="10" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="26" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </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_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="8" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="14" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="14" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="25" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Erythema nodosum</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Granuloma annulare</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="14" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="11" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Palmoplantar keratoderma</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Panniculitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="47" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="70" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="63" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="14" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Sensitive skin</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Stasis dermatitis</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Vitiligo</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="19" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="25" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="6" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_at_risk="0"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E5" subjects_at_risk="0"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="267"/>
                <counts group_id="E7" subjects_at_risk="0"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="264"/>
                <counts group_id="E9" subjects_at_risk="0"/>
              </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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>862 778 8300</phone>
      <email>Novartis.email@Novartis.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/NCT02967692
org study id: CPDR001F2301
secondary id: 2016-002794-35
nct id: NCT02967692
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody
      (Spartalizumab (PDR001)), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in
      unresectable or metastatic BRAF V600 mutant melanoma
This study is designed as a Phase III, multi-center study consisting of three parts:

        -  Part 1, known as the Safety Run-in, is an open-label part aimed at determining the
           recommended Phase III regimen (RP3R) of spartalizumab in combination with dabrafenib and
           trametinib for previously untreated subjects with BRAF V600 mutant unresectable or
           metastatic melanoma (Stage IIIC/IV per AJCC edition 7). In Part 1, spartalizumab was
           administered at a starting dose level (DL1) of 400 mg every 4 weeks (Q4W), along with
           fixed doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily). The
           RP3R for Part 3 was determined using the Bayesian Logistic Regression Model (BLRM) with
           escalation with overdose control (EWOC) criteria.

        -  Part 2, referred to as the Biomarker Cohort, is an open-label section focused on
           characterizing the kinetics of immune biomarkers and potential immune resistance
           mechanisms. Part 2 started when the fourth subject in dose level 1 (DL1) of Part 1
           completed approximately 4 weeks of study treatment, and fewer than 3 dose-limiting
           toxicities (DLTs) were observed. Participants in Part 2 receive PDR001 (spartalizumab)
           at a dosage of 400 mg Q4W, in combination with dabrafenib (150 mg BID) and trametinib (2
           mg QD).

        -  Part 3 is a double-blind, randomized, placebo-controlled phase that compares the
           efficacy and safety of spartalizumab in combination with dabrafenib and trametinib to
           placebo in combination with dabrafenib and trametinib. Part 3 was initiated after
           determining the RP3R for the combination of spartalizumab with dabrafenib and trametinib
           in Part 1. Subjects were randomized in a 1:1 ratio to receive either the RP3R dose of
           spartalizumab identified in Part 1 or placebo, along with dabrafenib (150 mg BID) and
           trametinib (2 mg QD).

      For all parts of the study, the treatment is continued until the subject experiences any of
      the following events: disease progression according to RECIST 1.1 as determined by the
      Investigator, unacceptable toxicity, initiation of a new anti-neoplastic therapy, pregnancy,
      withdrawal of consent, physician's decision, loss to follow-up, death, or termination of the
      study by the Sponsor. Safety evaluations are conducted for all subjects for up to 150 days
      after the last dose of spartalizumab/placebo (safety follow-up period).

      Subjects who discontinue study treatment without disease progression as per RECIST 1.1
      continue with tumor assessments according to the protocol until documented disease
      progression, withdrawal of consent, loss to follow-up, or death, regardless of the initiation
      of new anti-neoplastic therapy (efficacy follow-up period).

      Subjects enter the survival follow-up period after completing the safety follow-up period or
      experiencing disease progression as per RECIST 1.1 or response criteria for immunotherapy,
      whichever period is longer (survival follow-up period).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Part 1 and Part 2 are open- label. Part 3 is double-blind and randomized.
measure: Safety Run-In (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)
time frame: Up to 8 weeks (Part 1)
description: DLT was defined as an adverse event or abnormal laboratory value that was unrelated to disease, disease progression, inter-current illness, or concomitant medications and occured within 8 weeks of treatment with spartalizumab in combination with dabrafenib and trametinib. The DLT criteria included Grade 4 hematological adverse events, Grade 4 bilirubin elevation, specific gastrointestinal adverse events, symptomatic serum amylase or lipase elevation, Grade 3 or higher hypertension, Grade 3 or higher cardiac events, Grade 2 or higher pneumonitis, Grade 3 or higher immune-related toxicities, infusion-related reactions, other clinically significant adverse events, and toxicities leading to a dosing delay of over 12 weeks. NCI CTCAE v4.03 was used for grading DLTs
measure: Biomarker Cohort (Part 2): Change From Baseline in Programmed Cell Death-ligand 1 (PD-L1) Expression Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
time frame: Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days
description: Change from baseline in PD-L1 expression (as determined by immunohistochemistry in tissue samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2
measure: Biomarker Cohort (Part 2): Change From Baseline in CD8+ Cells Upon Treatment With Spartalizumab in Combination With Dabrafenib and Trametinib
time frame: Baseline, Cycle 1 Day 15 and Cycle 3 Day 1 (Part 2). Each cycle is 28 days
description: Change from baseline in CD8+ cells (as determined by flow cytometry in blood samples) upon treatment with spartalizumab in combination with dabrafenib and trametinib in participants from Part 2
measure: Randomized (Part 3): Progression-Free Survival (PFS) as Per Investigator's Assessment by RECIST 1.1
time frame: Up to disease progression or death due to any cause, whichever occurs first, assessed up to 2.8 years (Part 3)
description: Progression-free survival was defined as the time from the date of first dose to the date of the first documented radiological progression per investigator's assessment according to RECIST 1.1 or death due to any cause. The distribution of PFS was estimated using the Kaplan-Meier (KM) method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.
measure: Overall Survival (OS)
time frame: Up to death due to any cause, assessed up to approximately 5 years
description: Overall survival is defined as the time from date of randomization to date of death due to any cause
measure: Overall Response Rate (ORR) as Per Investigator's Assessment by RECIST 1.1
time frame: Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 years
description: ORR was defined as the percentage of subjects with confirmed best overall response of complete response (CR) or partial response (PR), as per investigator's assessment by RECIST 1.1.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters
measure: Duration of Response (DOR) as Per Investigator's Assessment by RECIST 1.1
time frame: From first documented response to date of first documented progression or death, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3)
description: DOR was defined as the time from first documented response of CR or PR to date of first documented progression or death, according to RECIST 1.1 criteria. The distribution of DOR was estimated using the KM method.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters
measure: Disease Control Rate (DCR) as Per Investigator's Assessment by RECIST 1.1
time frame: Part 1: Up to 3.3 years. Part 2: Up to 3 years. Part 3: Up to 2.8 year
description: DCR was defined as the percentage of participants with CR or PR or subjects with stable disease (SD) lasting for a duration of at least 24 weeks as per local review according to RECIST 1.1 criteria.
CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.
measure: Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status Scores
time frame: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
description: The EORTC QLQ-C30 was a 30-item questionnaire that patients complete, consisting of both multi-item scales and single-item measures. It included five functional scales, three symptom scales, six single items, and a Global Health Status/Quality of Life (GHS/QoL) scale.
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.
The change from baseline in GHS/QoL scores was calculated. A positive change from baseline indicated improvement in the patient's quality of life.
measure: Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Physical Functioning Scale Scores
time frame: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
description: The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The EORTC QLQ-C30 physical functioning scale measured a patient's ability to carry out daily activities and tasks requiring physical exertion. It consisted of five questions asking patients to rate their level of physical functioning, with response options ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating better physical functioning.
The change from baseline in physical functioning scale scores was calculated. A positive change from baseline indicated improvement in physical functioning.
measure: Randomized (Part 3): Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Pain Symptom Scale Scores
time frame: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
description: The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The EORTC QLQ-C30 pain symptom scale was one of the symptom scales in the questionnaire, which measured the severity of pain experienced by the patient. The pain symptom scale consisted of two items, one measuring the severity of pain and the other measuring the use of painkillers. The items were rated on a 4-point scale ranging from 1="not at all" to 4="very much". The scores for each item were summed and transformed to a 0 to 100 scale, with higher scores indicating more severe pain.
The change from baseline in pain symptom scale scores was calculated. A negative change from baseline indicated improvement.
measure: Randomized (Part 3): Time to 10 Point Definitive Deterioration in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30- Global Health Status
time frame: From baseline to date of at least 10 points relative to baseline worsening of the global health status score or death due to any cause, up to 2.8 years (Part 3)
description: The EORTC QLQ-C30 was a patient completed 30 item questionnaire that was composed of both multi-item scales and single-item measures. These included five functional scales, three symptom scales, six single items and a global health status/QoL scale.
The GHS/QoL scale had seven possible response scores ranging from 1 (very poor) to 7 (excellent), which were averaged and transformed to a 0-100 scale. A higher score on this scale indicated a better quality of life.
The time to definitive 10 point deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10 points relative to baseline worsening of the GHS/QoL score or death due to any cause. If a subject had not had an event, the time to deterioration was censored at the date of the last adequate assessment. The distribution was estimated using KM method.
measure: Randomized (Part 3): Change From Baseline in Function Assessment Cancer Therapy-melanoma (FACT-M) Melanoma Subscale Score
time frame: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
description: The Functional Assessment of Cancer Therapy-Melanoma (FACT-M) quality of life questionnaire was composed of the FACT-General (FACT-G) plus the Melanoma Subscale and the Melanoma Surgery Subscale, which complemented the general scale with items specific to quality of life (QoL) in melanoma.
The Melanoma Subscale of FACT-M included 16 questions, with response options of 0= "Not at all", 1= "a little bit", 2= "somewhat", 3= "quite a bit" and 4= "very much". The FACT-M melanoma subscale score ranged from 0 to 64, with higher scores indicating a higher quality of life in relation to melanoma.
The change from baseline in melanoma subscale scores was calculated. A positive change from baseline indicated improvement.
measure: Randomized (Part 3): Change From Baseline in EuroQoL 5-level Instrument (EQ-5D-5L)- Visual Analog Scale (VAS) Score
time frame: From baseline to 60 days post progression, assessed up to 2.8 years (Part 3)
description: The EQ-5D-5L is a standardized questionnaire used to assess health-related quality of life, and it includes a Visual Analog Scale (VAS). The VAS score is obtained by asking the individual to rate their current health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
The change from baseline in EQ-5D-5L VAS score was calculated. A positive change from baseline indicates improvement in the health status.
measure: Randomized (Part 3): PFS as Per Investigator's Assessment by RECIST 1.1 by PD-L1 Expression
time frame: Up to disease progression or death due to any cause, up to 2.8 years (Part 3)
description: PFS was defined as the time from the date of first dose to the date of the first documented radiological progression as per investigator's assessment using RECIST 1.1 response criteria or death due to any cause. The distribution of PFS was estimated using the KM method. If a patient had not had an event at the time of data cut-off, progression-free survival was censored at the date of last adequate tumor assessment.
PFS analysis was performed by PD-L1 status (positive, negative) where a positive status was defined as having ≥ 1% expression and a negative status was defined as having < 1% expression.
measure: Randomized (Part 3): OS by PD-L1 Expression
time frame: Up to death due to any cause, up to 5 years
description: OS is defined as the time from date of randomization to date of death due to any cause.
OS analysis will be performed by PD-L1 subgroup (positive, negative) where a positive status is defined as having ≥ 1% expression and a negative status is defined as having < 1% expression.
measure: Spartalizumab Anti-drug Antibody (ADA) Prevalence at Baseline
time frame: Baseline
description: Spartalizumab ADA prevalence at baseline was calculated as the percentage of participants who had an spartalizumab ADA positive result at baseline.
measure: Spartalizumab ADA Incidence
time frame: Throughout study until 150 days after the last dose of spartalizumab, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3).
description: Spartalizumab ADA incidence was calculated as the percentage of participants who were treatment-induced spartalizumab ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted spartalizumab ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)
measure: Trough Concentration (Ctrough) for Spartalizumab
time frame: Pre-infusion on Day 1 of each Cycle starting from Cycle 2, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
description: Ctrough for spartalizumab refers to the serum concentration of spartalizumab immediately prior to the administration of a dose of spartalizumab on Day 1 of Cycle 2 and later cycles.
measure: Pre-dose Plasma Concentration for Dabrafenib
time frame: Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
description: Plasma concentration of dabrafenib immediately prior to the administration of a dose of dabrafenib.
measure: Pre-dose Plasma Concentration for Trametinib
time frame: Pre-infusion on Day 1 of every cycle from Cycle 2 to 12, and then every 6 cycles from Cycle 18 to 36, up to 3.3 years (Part 1), 3 years (Part 2) and 2.8 years (Part 3). Cycle=28 days
description: Plasma concentration of trametinib immediately prior to the administration of a dose of trametinib.
measure: Number of Participants With Dose Interruptions
time frame: From baseline to end of treatment, up to 5 years
description: Number of participants with dose interruptions for spartalizumab, dabrafenib and trametinib
measure: Number of Participants With Dose Reductions
time frame: From baseline to end of treatment, up to 5 years
description: Number of patients with dose reductions for spartalizumab, dabrafenib and trametinib
measure: Relative Dose Intensity
time frame: From baseline to end of treatment, up to 5 years
description: Relative dose intensity for spartalizumab, dabrafenib and trametinib computed as the ratio of dose intensity and planned dose intensity
arm group label: Part 1: Safety run-in Cohort
arm group type: Experimental
description: In Part 1, participants are treated at different dose levels to determine the recommended Phase 3 regimen of spartalizumab in combination with dabrafenib and trametinib. The starting dose of spartalizumab is 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
arm group label: Part 2: Biomarker cohort
arm group type: Experimental
description: In Part 2, participants are treated with spartalizumab 400 mg Q4W in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD).
arm group label: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib
arm group type: Experimental
description: In Part 3, participants are randomized to receive spartalizumab at the RP3R identified in Part 1 (400 mg Q4W) in combination with approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
arm group label: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib
arm group type: Placebo Comparator
description: In Part 3, participants are randomized to receive matching placebo in combination with the approved dose of dabrafenib (150 mg BID) and trametinib (2 mg QD)
intervention type: Biological
intervention name: Spartalizumab
description: Spartalizumab powder for solution is used in Part 1 and Part 2, and as concentrate for solution for infusion for Part 3. Spartalizumab is administered via intravenous infusion over 30 minutes once every 4 weeks
arm group label: Part 1: Safety run-in Cohort
arm group label: Part 2: Biomarker cohort
arm group label: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib
other name: PDR001
intervention type: Other
intervention name: Placebo
description: Placebo is administered via intravenous infusion over 30 minutes once every 4 weeks
arm group label: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib
intervention type: Drug
intervention name: Dabrafenib
description: Dabrafenib 150 mg capsules BID is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions.
arm group label: Part 1: Safety run-in Cohort
arm group label: Part 2: Biomarker cohort
arm group label: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib
arm group label: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib
intervention type: Drug
intervention name: Trametinib
description: Trametinib 2 mg tablets QD is administered orally for Days 1-28 of a 28-day cycle, in fasting conditions
arm group label: Part 1: Safety run-in Cohort
arm group label: Part 2: Biomarker cohort
arm group label: Part 3- Arm 1: Spartalizumab in combination with dabrafenib and trametinib
arm group label: Part 3- Arm 2: Placebo in combination with dabrafenib and trametinib
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Chile
country: Czechia
country: Denmark
country: France
country: Germany
country: Greece
country: Hungary
country: Israel
country: Italy
country: Japan
country: Mexico
country: Netherlands
country: Norway
country: Poland
country: Portugal
country: Russian Federation
country: Spain
country: Sweden
country: Switzerland
country: Thailand
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Trametinib
mesh term: Dabrafenib
mesh term: Spartalizumab
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 