<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01677741</url>
  </required_header>
  <id_info>
    <org_study_id>116013</org_study_id>
    <secondary_id>2012-001499-12</secondary_id>
    <secondary_id>CDRB436A2102</secondary_id>
    <nct_id>NCT01677741</nct_id>
  </id_info>
  <brief_title>A Study to Determine Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib In Children and Adolescent Subjects</brief_title>
  <official_title>Phase I/IIa, 2-Part, Multi-Center, Single-Arm, Open-Label Study to Determine the Safety, Tolerability and Pharmacokinetics of Oral Dabrafenib in Children and Adolescent Subjects With Advanced BRAF V600-Mutation Positive Solid Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent&#xD;
      patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation&#xD;
      study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6&#xD;
      Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and&#xD;
      clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients&#xD;
      participated in only either part 1 or part 2 of the study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 1 was a dose escalation study in subjects with any BRAF V600 mutation-positive solid&#xD;
      tumor, designed to optimize efficiency of enrollment, minimize the number of subjects being&#xD;
      treated at potentially sub-efficacious dose levels, and incorporating the evolving&#xD;
      pharmacokinetic, safety and efficacy data from the adult development program. Dose escalation&#xD;
      part of the study was to determine the maximum tolerated dose (MTD) and recommend the dose&#xD;
      for phase 2 studies (RP2D). An MTD has not been identified for dabrafenib in the adult&#xD;
      population. This does not preclude the identification of an MTD in the pediatric population.&#xD;
      Modified RSD was employed to determine the MTD. Part 1 used dual criteria of dose limiting&#xD;
      toxicity (DLT) and observed dabrafenib exposures to make decisions to advance to the next&#xD;
      dose level. Target exposure criteria based on adults treated at the approved adult dose of&#xD;
      300 mg (150 mg given BID) were observed in this study before meeting criteria for stopping&#xD;
      dose escalation due to observations of DLTs, and served as the criteria for determining the&#xD;
      RP2D for dabrafenib in pediatric subjects. Thus, MTD has not been established in pediatric&#xD;
      population, similar to the previous dose finding efforts in adult subjects.&#xD;
&#xD;
      Part 2 was a tumor specific expansion study to further evaluate the safety/tolerability&#xD;
      profile and to discover possible clinical efficacy of dabrafenib in 4 tumor-specific&#xD;
      pediatric populations known to have BRAFV600 activation: high grade glioma (HGG), low grade&#xD;
      glioma (LGG), Langerhans cell histiocytosis (LCH), miscellaneous tumors including melanoma&#xD;
      and papillary thyroid carcinoma (Other). The exposures for subjects dosed on the basis of&#xD;
      weight were also evaluated by age categories.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2013</start_date>
  <completion_date type="Actual">December 4, 2020</completion_date>
  <primary_completion_date type="Actual">December 4, 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)</measure>
    <time_frame>From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months</time_frame>
    <description>The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Concentration (Cmax) of Dabrafenib</measure>
    <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib was listed and summarized using descriptive statistics.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration-time Curve Over the Dosing Interval (AUC(0-τ)) and AUC From Zero to Infinity (AUC(0-inf)) of Dabrafenib</measure>
    <time_frame>Week 1 Day 1</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC(0-τ) and AUC(0-inf) of dabrafenib were to be listed and summarized using descriptive statistics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-dose (Trough) Concentration (C Tau) of Dabrafenib and Its Metabolites</measure>
    <time_frame>Week 3 Day 15</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Pre-dose (trough) concentration (C tau) was to be listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The AUC(0-t) of Dabrafenib Metabolites</measure>
    <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC[0-t]) dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The AUC(0-tau) of Dabrafenib and Its Metabolites</measure>
    <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-tau) of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Dabrafenib</measure>
    <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL/F of dabrafenib was to be listed and summarized using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) of Dabrafenib Metabolites</measure>
    <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were listed and summarized using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites</measure>
    <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Half Life (T½) of Dabrafenib and Its Metabolites</measure>
    <time_frame>Week 3 Day 15</time_frame>
    <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) was listed and summarized using descriptive statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)</measure>
    <time_frame>From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months</time_frame>
    <description>The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Event and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for Low Grade Glioma (LLG) Subjects</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for High Grade Glioma (HGG) Subjects</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Weight on Total Apparent Clearance (CL/F) of Dabrafenib Estimated With a PopPK Model</measure>
    <time_frame>Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.</time_frame>
    <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on total apparent clearance (CL/F) of dabrafenib estimated with the PopPK model is summarized in this record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Weight on Volume of Distribution (V/F) of Dabrafenib Estimated With a PopPK Model</measure>
    <time_frame>Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.</time_frame>
    <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on volume of distribution (V/F) of dabrafenib estimated with the PopPK model is summarized in this record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Weight on Absorption Rate (ka) of Dabrafenib Estimated With a PopPK Model</measure>
    <time_frame>Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.</time_frame>
    <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on absorption rate (ka) of dabrafenib estimated with a PopPK model is summarized in this record.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of Weight on Coefficients for Significant Covariates of Dabrafenib Estimated With a PopPK Model</measure>
    <time_frame>Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.</time_frame>
    <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on coefficients for significant covariates of dabrafenib estimated with a PopPK model is summarized in this record.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Neoplasms, Brain</condition>
  <arm_group>
    <arm_group_label>Part 1: Dabrafenib treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three subjects will receive a single dose of 3 mg/kg dabrafenib on Day 1 and repeat dose will begin from Day 2, evenly divided in two daily doses. Once all 3 subjects have been fully evaluated for the first 28 days (including Day 15 PK) and no DLTs are observed, a next subject will be enrolled at the next higher dose levels (i.e., dose escalation to 3.75 mg/kg [+1] and may be further to 4.5 mg/kg [+2] and so on). If all 3 subjects have not been fully evaluated for the first 28 days or 1 DLT occurred, the fourth subject will be enrolled at the same dose level. If 2 or more DLTs are observed, the next subject will be enrolled at the next lower dose level (i.e., de-escalated to 2.25 mg/kg [-1] and may be further to 1.5 mg/kg [-2]). Similarly, the process is repeated for the fifth and sixth subjects in a cohort. All subjects will receive treatment till end of study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Cohort 1 Low-Grade Gliomas with BRAF V600 mutations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Cohort 2 High-Grade Gliomas with BRAF V600 mutations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Cohort 3 LCH with BRAF V600 mutations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Cohort 4 Melanoma and PTC with BRAF V600 mutations</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabrafenib</intervention_name>
    <description>Dabrafenib is available as 50 mg or 75 mg capsules and as oral suspension (10 mg/mL for subjects unable to swallow capsules). Dabrafenib (either formulation) will be administered orally as a single dose on Day 1 and twice daily from Day 2, based on weight at the appropriate study dose level.</description>
    <arm_group_label>Part 1: Dabrafenib treatment</arm_group_label>
    <arm_group_label>Part 2: Cohort 1 Low-Grade Gliomas with BRAF V600 mutations</arm_group_label>
    <arm_group_label>Part 2: Cohort 2 High-Grade Gliomas with BRAF V600 mutations</arm_group_label>
    <arm_group_label>Part 2: Cohort 3 LCH with BRAF V600 mutations</arm_group_label>
    <arm_group_label>Part 2: Cohort 4 Melanoma and PTC with BRAF V600 mutations</arm_group_label>
    <other_name>DRB436</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent - a signed informed consent and/or assent (as age&#xD;
             appropriate) will be obtained according to institutional guidelines.&#xD;
&#xD;
          -  Male or female &gt;=12 months and &lt;18 years of age at the time of signing the informed&#xD;
             consent form.&#xD;
&#xD;
          -  Recurrent disease, refractory disease, or progressive disease after having received at&#xD;
             least one standard therapy for their disease. Note: Subjects with metastatic (and&#xD;
             surgically unresectable) melanoma can be enrolled for first-line treatment; Melanoma&#xD;
             subjects with CNS involvement may be enrolled.&#xD;
&#xD;
          -  At least one evaluable lesion.&#xD;
&#xD;
          -  BRAF V600 mutation-positive tumor as confirmed in a Clinical Laboratory Improvement&#xD;
             Amendments (CLIA)-approved laboratory or equivalent (the local BRAF testing may be&#xD;
             subject to subsequent verification by centralized testing; centralized testing can&#xD;
             confirm V600E and V600K mutations only).&#xD;
&#xD;
          -  Performance score of &gt;=50% according to the Karnofsky/Lansky performance status scale&#xD;
             (subjects with a performance status of &lt;=50% can be enrolled if the subject's&#xD;
             confinement to bed and inability to carry out activities is due solely to&#xD;
             cancer-related pain, as assessed by the investigator).&#xD;
&#xD;
          -  Females of child-bearing potential (with negative serum pregnancy test within 7 days&#xD;
             prior to the first dose of study medication) must be willing to practice acceptable&#xD;
             methods of birth control .&#xD;
&#xD;
          -  Sexually active males, who do not agree to abstinence, must be willing to use a condom&#xD;
             during intercourse while taking the study drug, and for 16 weeks after stopping&#xD;
             treatment and should not father a child in this period.&#xD;
&#xD;
          -  Must have adequate organ function as defined by the following values: Adequate bone&#xD;
             marrow function defined as-absolute neutrophil count (ANC) &gt;=1000/ microliter (µL),&#xD;
             hemoglobin &gt;=8.0 grams (g)/ deciliter (dL) (may receive red blood cell transfusions),&#xD;
             platelets &gt;=75,000/µL (transfusion independent, defined as not receiving platelet&#xD;
             transfusions within a 7 day period prior to enrollment).&#xD;
&#xD;
          -  Adequate renal and metabolic function defined as: calculated glomerular filtration&#xD;
             rate (eGFR) (Schwartz formula), or radioisotope GFR &gt;=90 milliliters/minutes&#xD;
             (mL/min)/1.73 meter square (m^2); or a serum creatinine within the institutional&#xD;
             reference range upper limit of normal (for age/gender, if available).&#xD;
&#xD;
          -  Adequate liver function defined as: bilirubin (sum of conjugated + unconjugated) &lt;=1.5&#xD;
             x upper limit of normal (ULN) for age, aspartate aminotransaminase (AST) and alanine&#xD;
             transaminase (ALT) &lt;=2.5 x ULN; AST/ALT may be &lt;5 x ULN at baseline if disease under&#xD;
             treatment involves the liver (requires radiographic confirmation of liver&#xD;
             involvement).&#xD;
&#xD;
          -  Adequate cardiac function defined as: left ventricular ejection fraction (LVEF) of&#xD;
             either &gt;=50% by ECHO or greater than institutional lower limit of normal (LLN) by&#xD;
             echocardiogram (ECHO) (while not receiving medications for cardiac function),&#xD;
             corrected QT using Bazett's (QTcB) interval &lt;450 milliseconds (msecs).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Part 2 ONLY: Previous treatment with dabrafenib, another RAF inhibitor, or a&#xD;
             mitogen-activated protein kinase (MEK) inhibitor (exception: prior treatment with&#xD;
             sorafenib is permitted).&#xD;
&#xD;
          -  Malignancy OTHER than the BRAF mutant malignancy under study.&#xD;
&#xD;
          -  Had chemotherapy or radiotherapy within 3 weeks (or 6 weeks for nitrosoureas or&#xD;
             mitomycin C) prior to administration of the first dose of study treatment.&#xD;
&#xD;
          -  The subject has received an investigational product within the following time period&#xD;
             prior to the first dosing day in the current study: 28 days or 5 half-lives or twice&#xD;
             the duration of the biological effect of the investigational product (whichever is&#xD;
             warranted by the data).&#xD;
&#xD;
          -  History of another malignancy. Exception: (a) Subjects who have been successfully&#xD;
             treated and are disease-free for 3 years, (b) a history of completely resected&#xD;
             non-melanoma skin cancer, (c) successfully treated in situ carcinoma, (d) CLL in&#xD;
             stable remission are eligible.&#xD;
&#xD;
          -  Current use of a prohibited medication or herbal preparation or requires any of these&#xD;
             medications during the study.&#xD;
&#xD;
          -  Unresolved toxicity greater than National Cancer Institute Common Terminology Criteria&#xD;
             for Adverse Events (NCI CTCAE) v4.0 Grade 2 or higher from previous anti-cancer&#xD;
             therapy, including major surgery except those that in the opinion of the investigator&#xD;
             are not clinically relevant given the known safety/toxicity profile of dabrafenib&#xD;
             (e.g., alopecia and/or peripheral neuropathy related to platinum or vinca alkaloid&#xD;
             based chemotherapy).&#xD;
&#xD;
          -  Has leukaemia.&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to dabrafenib and its excipients.&#xD;
&#xD;
          -  Autologous or allogeneic stem cell transplant within 3 months prior to enrolment&#xD;
             [NOTE: subjects with evidence of active graph versus host disease are excluded].&#xD;
&#xD;
          -  History of myocardial infarction, severe or unstable angina, peripheral vascular&#xD;
             disease or familial QTc prolongation.&#xD;
&#xD;
          -  Subjects with abnormal cardiac valve morphology (&gt;=grade 2) documented by&#xD;
             echocardiogram (NOTE: subjects with grade 1 abnormalities [i.e., mild&#xD;
             regurgitation/stenosis] can be entered on study).&#xD;
&#xD;
          -  Subjects with moderate valvular thickening.&#xD;
&#xD;
          -  Known, uncontrolled cardiac arrhythmias (except sinus arrhythmia) within the past 24&#xD;
             weeks&#xD;
&#xD;
          -  Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease&#xD;
             or uncontrolled infection), psychological, familial, sociological, or geographical&#xD;
             conditions that do not permit compliance with the protocol; or unwillingness or&#xD;
             inability to follow the procedures required in the protocol.&#xD;
&#xD;
          -  Presence of active GI disease or other condition (e.g., small bowel or large bowel&#xD;
             resection) that will interfere significantly with the absorption of drugs.&#xD;
&#xD;
          -  Hepatitis B Virus, or Hepatitis C Virus infection (subjects with laboratory evidence&#xD;
             of Hepatitis B Virus clearance may be enrolled).&#xD;
&#xD;
          -  Pregnant females as determined by positive human chorionic gonadotropin (hCG) test at&#xD;
             screening or prior to dosing.&#xD;
&#xD;
          -  Lactating females who are actively breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>17 Years</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>Novartis Investigative Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016-7710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105-3678</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Copenhagen</city>
        <zip>DK-2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Marseille Cedex 5</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris cedex 05</city>
        <zip>75248</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Paris cedex 12</city>
        <zip>75571</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Toulouse cedex 9</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Wuerttemberg</state>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Regensburg</city>
        <state>Bayern</state>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</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>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Esplugues De Llobregat. Barcelona</city>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </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>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>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <results_first_submitted>June 3, 2021</results_first_submitted>
  <results_first_submitted_qc>October 27, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 24, 2021</results_first_posted>
  <last_update_submitted>October 27, 2021</last_update_submitted>
  <last_update_submitted_qc>October 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Children and Adolescents</keyword>
  <keyword>BRAF</keyword>
  <keyword>dabrafenib</keyword>
  <keyword>dose escalation</keyword>
  <keyword>BRF116013</keyword>
  <keyword>V600-mutation positive</keyword>
  <keyword>BRF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dabrafenib</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>August 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT01677741/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>November 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT01677741/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted in 19 centers in eight participating countries: Australia (1), Canada (1), Denmark (1), Germany (1), France (4), Spain (1), United Kingdom (2), and United States (8).</recruitment_details>
      <pre_assignment_details>Patients participated in only either Part 1 (Dose Escalation) or Part 2 (Tumor specific expansion) of the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="P2">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="P3">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="P4">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="P5">
          <title>Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)</title>
          <description>Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="P6">
          <title>Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)</title>
          <description>Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="P7">
          <title>Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)</title>
          <description>Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="P8">
          <title>Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)</title>
          <description>Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="28"/>
                <participants group_id="P7" count="11"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>DLT Evaluable Population</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>PK Population</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="28"/>
                <participants group_id="P7" count="11"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="28"/>
                <participants group_id="P7" count="11"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="11"/>
                <participants group_id="P6" count="20"/>
                <participants group_id="P7" count="4"/>
                <participants group_id="P8" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Enrolled in a rollover study</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="7"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="B2">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="B3">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="B4">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="B5">
          <title>Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)</title>
          <description>Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="B6">
          <title>Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)</title>
          <description>Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="B7">
          <title>Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)</title>
          <description>Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="B8">
          <title>Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)</title>
          <description>Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="B9">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="17"/>
            <count group_id="B6" value="28"/>
            <count group_id="B7" value="11"/>
            <count group_id="B8" value="2"/>
            <count group_id="B9" value="85"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.33" spread="5.132"/>
                    <measurement group_id="B2" value="11.30" spread="5.355"/>
                    <measurement group_id="B3" value="6.58" spread="5.445"/>
                    <measurement group_id="B4" value="7.17" spread="3.189"/>
                    <measurement group_id="B5" value="9.65" spread="5.195"/>
                    <measurement group_id="B6" value="12.32" spread="3.692"/>
                    <measurement group_id="B7" value="5.52" spread="3.390"/>
                    <measurement group_id="B8" value="9.50" spread="10.607"/>
                    <measurement group_id="B9" value="9.46" spread="5.051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="8"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="4"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="17"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="22"/>
                    <measurement group_id="B7" value="11"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)</title>
        <description>The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.</description>
        <time_frame>From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months</time_frame>
        <population>Safety population. Deaths occurring more than 28 days after the last dose of study drug were not included in the on-treatment deaths. All deaths included on-treatment deaths and those occurring more than 28 days after the last dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)</title>
          <description>The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.</description>
          <population>Safety population. Deaths occurring more than 28 days after the last dose of study drug were not included in the on-treatment deaths. All deaths included on-treatment deaths and those occurring more than 28 days after the last dose of study drug.</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="3"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On-treatment deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse Events (AEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs suspected to be drug related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events (SAEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs suspected to be drug related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal SAEs suspected to be drug related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs requiring dose interruptions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs requiring dose reductions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs requiring dose reductions or interruptions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Concentration (Cmax) of Dabrafenib</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib was listed and summarized using descriptive statistics.</description>
        <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
        <population>Pharmacokinetic population. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) of Dabrafenib</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib was listed and summarized using descriptive statistics.</description>
          <population>Pharmacokinetic population. Only participants with an evaluable PK sample collected at each timepoint were included in the analysis.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="27"/>
                <count group_id="O6" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1 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="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1820" spread="38.0"/>
                    <measurement group_id="O2" value="1250" spread="61.5"/>
                    <measurement group_id="O3" value="1250" spread="529.9"/>
                    <measurement group_id="O4" value="1900" spread="45.0"/>
                    <measurement group_id="O5" value="1340" spread="82.6"/>
                    <measurement group_id="O6" value="1550" spread="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3 Day 15</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1470" spread="37.7"/>
                    <measurement group_id="O2" value="1260" spread="48.1"/>
                    <measurement group_id="O3" value="1580" spread="49.2"/>
                    <measurement group_id="O4" value="1710" spread="56.4"/>
                    <measurement group_id="O5" value="1450" spread="57.8"/>
                    <measurement group_id="O6" value="1310" spread="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration-time Curve Over the Dosing Interval (AUC(0-τ)) and AUC From Zero to Infinity (AUC(0-inf)) of Dabrafenib</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC(0-τ) and AUC(0-inf) of dabrafenib were to be listed and summarized using descriptive statistics.</description>
        <time_frame>Week 1 Day 1</time_frame>
        <population>Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-t) and AUC (0-inf) PK parameters were collected/calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration-time Curve Over the Dosing Interval (AUC(0-τ)) and AUC From Zero to Infinity (AUC(0-inf)) of Dabrafenib</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC(0-τ) and AUC(0-inf) of dabrafenib were to be listed and summarized using descriptive statistics.</description>
          <population>Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-t) and AUC (0-inf) PK parameters were collected/calculated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pre-dose (Trough) Concentration (C Tau) of Dabrafenib and Its Metabolites</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Pre-dose (trough) concentration (C tau) was to be listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).</description>
        <time_frame>Week 3 Day 15</time_frame>
        <population>Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-dose (Trough) Concentration (C Tau) of Dabrafenib and Its Metabolites</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Pre-dose (trough) concentration (C tau) was to be listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).</description>
          <population>Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected were included in the analysis.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="26"/>
                <count group_id="O6" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>dabrafenib</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="276.5"/>
                    <measurement group_id="O2" value="39.8" spread="176.1"/>
                    <measurement group_id="O3" value="50.7" spread="121.0"/>
                    <measurement group_id="O4" value="11.0" spread="67.5"/>
                    <measurement group_id="O5" value="42.7" spread="135.9"/>
                    <measurement group_id="O6" value="22.8" spread="209.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hydroxy-dabrafenib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>carboxy-dabrafenib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>desmethyl-dabrafenib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The AUC(0-t) of Dabrafenib Metabolites</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC[0-t]) dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.</description>
        <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
        <population>Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-t) PK parameters were collected/calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>The AUC(0-t) of Dabrafenib Metabolites</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC[0-t]) dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.</description>
          <population>Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-t) PK parameters were collected/calculated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The AUC(0-tau) of Dabrafenib and Its Metabolites</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-tau) of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.</description>
        <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
        <population>Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-tau) PK parameters were collected/calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>The AUC(0-tau) of Dabrafenib and Its Metabolites</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-tau) of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.</description>
          <population>Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable AUC(0-tau) PK parameters were collected/calculated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Dabrafenib</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL/F of dabrafenib was to be listed and summarized using descriptive statistics.</description>
        <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
        <population>Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable CL/F PK parameters were collected/calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Dabrafenib</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL/F of dabrafenib was to be listed and summarized using descriptive statistics.</description>
          <population>Pharmacokinetic population. Due to limited dabrafenib PK data collected for Day 1 (up to 4 hours post-dose PK data only), no reliable CL/F PK parameters were collected/calculated.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Concentration (Cmax) of Dabrafenib Metabolites</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were listed and summarized using descriptive statistics.</description>
        <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
        <population>Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected at each timepoint were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Concentration (Cmax) of Dabrafenib Metabolites</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were listed and summarized using descriptive statistics.</description>
          <population>Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected at each timepoint were included in the analysis.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="27"/>
                <count group_id="O6" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>hydroxy-dabrafenib @ Week 1 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="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="811" spread="24.7"/>
                    <measurement group_id="O2" value="662" spread="66.7"/>
                    <measurement group_id="O3" value="473" spread="1643.7"/>
                    <measurement group_id="O4" value="1370" spread="43.9"/>
                    <measurement group_id="O5" value="694" spread="77.9"/>
                    <measurement group_id="O6" value="894" spread="58.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hydroxy-dabrafenib @ Week 3 Day 15</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="673" spread="62.8"/>
                    <measurement group_id="O2" value="726" spread="37.6"/>
                    <measurement group_id="O3" value="752" spread="32.8"/>
                    <measurement group_id="O4" value="1010" spread="51.5"/>
                    <measurement group_id="O5" value="772" spread="50.1"/>
                    <measurement group_id="O6" value="711" spread="43.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>carboxy-dabrafenib @ Week 1 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="10"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1720" spread="90.6"/>
                    <measurement group_id="O2" value="1300" spread="55.7"/>
                    <measurement group_id="O3" value="824" spread="291.3"/>
                    <measurement group_id="O4" value="4250" spread="67.0"/>
                    <measurement group_id="O5" value="1650" spread="161.2"/>
                    <measurement group_id="O6" value="2330" spread="97.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>carboxy-dabrafenib @ Week 3 Day 15</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4700" spread="51.7"/>
                    <measurement group_id="O2" value="6410" spread="28.0"/>
                    <measurement group_id="O3" value="9650" spread="35.9"/>
                    <measurement group_id="O4" value="11200" spread="28.4"/>
                    <measurement group_id="O5" value="8280" spread="45.9"/>
                    <measurement group_id="O6" value="7970" spread="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>desmethyl-dabrafenib @ Week 1 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="10"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.0" spread="27.3"/>
                    <measurement group_id="O2" value="6.55" spread="80.5"/>
                    <measurement group_id="O3" value="15.4" spread="103.9"/>
                    <measurement group_id="O4" value="23.7" spread="53.8"/>
                    <measurement group_id="O5" value="10.7" spread="159.4"/>
                    <measurement group_id="O6" value="10.1" spread="88.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>desmethyl-dabrafenib @ Week 3 Day 15</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="194" spread="219.4"/>
                    <measurement group_id="O2" value="311" spread="78.9"/>
                    <measurement group_id="O3" value="317" spread="324.9"/>
                    <measurement group_id="O4" value="238" spread="45.6"/>
                    <measurement group_id="O5" value="328" spread="38.8"/>
                    <measurement group_id="O6" value="274" spread="77.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).</description>
        <time_frame>Week 1 Day 1, Week 3 Day 15</time_frame>
        <population>Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected at each timepoint were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).</description>
          <population>Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected at each timepoint were included in the analysis.</population>
          <units>Hour (hr)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="27"/>
                <count group_id="O6" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>dabrafenib @ Week 1 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="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="2.00" upper_limit="2.00"/>
                    <measurement group_id="O2" value="2.00" lower_limit="2.00" upper_limit="4.00"/>
                    <measurement group_id="O3" value="2.00" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O4" value="2.00" lower_limit="2.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="2.00" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O6" value="2.00" lower_limit="0.50" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>dabrafenib @ Week 3 Day 15</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="1.00" upper_limit="2.00"/>
                    <measurement group_id="O2" value="2.00" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O3" value="2.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O4" value="2.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O5" value="2.00" lower_limit="1.00" upper_limit="6.00"/>
                    <measurement group_id="O6" value="2.00" lower_limit="1.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hydroxy-dabrafenib @ Week 1 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="10"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="4.00" lower_limit="2.00" upper_limit="4.00"/>
                    <measurement group_id="O3" value="3.00" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O4" value="3.00" lower_limit="2.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="4.00" lower_limit="2.00" upper_limit="4.00"/>
                    <measurement group_id="O6" value="4.00" lower_limit="2.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hydroxy-dabrafenib @ Week 3 Day 15</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O2" value="2.50" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O3" value="2.00" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O4" value="2.00" lower_limit="1.00" upper_limit="3.00"/>
                    <measurement group_id="O5" value="2.00" lower_limit="1.00" upper_limit="6.00"/>
                    <measurement group_id="O6" value="2.00" lower_limit="1.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>carboxy-dabrafenib @ Week 1 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="10"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="27"/>
                    <count group_id="O6" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O3" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O4" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="4.00" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O6" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>carboxy-dabrafenib @ Week 3 Day 15</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="26"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.00" lower_limit="4.00" upper_limit="8.00"/>
                    <measurement group_id="O2" value="4.00" lower_limit="3.00" upper_limit="8.00"/>
                    <measurement group_id="O3" value="4.00" lower_limit="3.00" upper_limit="8.00"/>
                    <measurement group_id="O4" value="4.00" lower_limit="3.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="4.00" lower_limit="0.00" upper_limit="8.00"/>
                    <measurement group_id="O6" value="4.00" lower_limit="2.00" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>desmethyl-dabrafenib @ Week 1 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="10"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O3" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O4" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                    <measurement group_id="O5" value="4.00" lower_limit="0.50" upper_limit="4.00"/>
                    <measurement group_id="O6" value="4.00" lower_limit="4.00" upper_limit="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>desmethyl-dabrafenib @ Week 3 Day 15</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="24"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="0.00" upper_limit="8.00"/>
                    <measurement group_id="O2" value="2.00" lower_limit="0.50" upper_limit="8.00"/>
                    <measurement group_id="O3" value="1.50" lower_limit="0.00" upper_limit="8.00"/>
                    <measurement group_id="O4" value="1.50" lower_limit="0.00" upper_limit="3.00"/>
                    <measurement group_id="O5" value="2.00" lower_limit="0.00" upper_limit="8.00"/>
                    <measurement group_id="O6" value="1.00" lower_limit="0.00" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Elimination Half Life (T½) of Dabrafenib and Its Metabolites</title>
        <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) was listed and summarized using descriptive statistics.</description>
        <time_frame>Week 3 Day 15</time_frame>
        <population>Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 4,5 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 4,5 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): All Patients at Recommended Dose Phase 2 (RP2D) of 5.25 mg/kg</title>
            <description>All patients at recommended dose phase 2 (RP2D) of 5.25 mg/kg in Part 2 study cohorts (Cohort 1 Low-Grade Gliomas (LGG), Cohort 2 High-Grade Gliomas (HGG), Cohort 3 Langerhans cell histiocytosis (LCH) and Cohort 4 Miscellaneous tumors including melanoma and papillary thyroid carcinoma (Other)) were pooled together.</description>
          </group>
        </group_list>
        <measure>
          <title>Elimination Half Life (T½) of Dabrafenib and Its Metabolites</title>
          <description>Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) was listed and summarized using descriptive statistics.</description>
          <population>Pharmacokinetic population. For each parameter, only participants with an evaluable PK sample collected were included in the analysis.</population>
          <units>Hour (hr)</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="10"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="25"/>
                <count group_id="O6" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>dabrafenib</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="8"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="25"/>
                    <count group_id="O6" value="29"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.98" spread="0.687"/>
                    <measurement group_id="O2" value="2.85" spread="1.58"/>
                    <measurement group_id="O3" value="2.74" spread="0.840"/>
                    <measurement group_id="O4" value="1.56" spread="0.359"/>
                    <measurement group_id="O5" value="3.03" spread="2.27"/>
                    <measurement group_id="O6" value="2.54" spread="2.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>hydroxy-dabrafenib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>carboxy-dabrafenib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>desmethyl-dabrafenib</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="0"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)</title>
        <description>The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Event and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.</description>
        <time_frame>From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months</time_frame>
        <population>Safety population. Deaths occurring more than 28 days after the last dose of study drug were not included in the on-treatment deaths. All deaths included on-treatment deaths and those occurring more than 28 days after the last dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)</title>
            <description>Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
          <group group_id="O2">
            <title>Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)</title>
            <description>Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)</title>
            <description>Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
          <group group_id="O4">
            <title>Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)</title>
            <description>Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)</title>
          <description>The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Event and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.</description>
          <population>Safety population. Deaths occurring more than 28 days after the last dose of study drug were not included in the on-treatment deaths. All deaths included on-treatment deaths and those occurring more than 28 days after the last dose of study drug.</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="17"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>On-treatment deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse Events (AEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs suspected to be drug related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events (SAEs)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs suspected to be drug related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal SAEs suspected to be drug related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs requiring dose interruptions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs requiring dose reductions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs requiring dose reductions or interruptions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for Low Grade Glioma (LLG) Subjects</title>
        <description>Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.</description>
        <time_frame>Up to 6 months</time_frame>
        <population>All treated population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)</title>
            <description>Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
          <group group_id="O5">
            <title>All LGG Subjects at Recommended Phase 2 Dose (RP2D)</title>
            <description>All LGG patients who have been assigned to Recommended Phase II Dose (RP2D) across Part 1 and Part 2.</description>
          </group>
          <group group_id="O6">
            <title>All LGG Subjects</title>
            <description>All LGG subjects in the study</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for Low Grade Glioma (LLG) Subjects</title>
          <description>Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.</description>
          <population>All treated population</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="24"/>
                <count group_id="O6" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for High Grade Glioma (HGG) Subjects</title>
        <description>Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.</description>
        <time_frame>Up to 6 months</time_frame>
        <population>All treated population</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)</title>
            <description>Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
          <group group_id="O4">
            <title>All HGG Subjects at Recommended Phase 2 Dose (RP2D)</title>
            <description>All HGG patients who have been assigned to Recommended Phase II Dose (RP2D) across Part 1 and Part 2.</description>
          </group>
          <group group_id="O5">
            <title>All HGG Subjects</title>
            <description>All HGG subjects in the study</description>
          </group>
        </group_list>
        <measure>
          <title>Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for High Grade Glioma (HGG) Subjects</title>
          <description>Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.</description>
          <population>All treated population</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="3"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="28"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Weight on Total Apparent Clearance (CL/F) of Dabrafenib Estimated With a PopPK Model</title>
        <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on total apparent clearance (CL/F) of dabrafenib estimated with the PopPK model is summarized in this record.</description>
        <time_frame>Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.</time_frame>
        <population>All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 and Part 2 - All Participants With PK Data</title>
            <description>Participants in the study (all doses and all tumor types) with available pharmacokinetic data</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Weight on Total Apparent Clearance (CL/F) of Dabrafenib Estimated With a PopPK Model</title>
          <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on total apparent clearance (CL/F) of dabrafenib estimated with the PopPK model is summarized in this record.</description>
          <population>All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.</population>
          <units>coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Weight on Volume of Distribution (V/F) of Dabrafenib Estimated With a PopPK Model</title>
        <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on volume of distribution (V/F) of dabrafenib estimated with the PopPK model is summarized in this record.</description>
        <time_frame>Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.</time_frame>
        <population>All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 and Part 2 - All Participants With PK Data</title>
            <description>Participants in the study (all doses and all tumor types) with available pharmacokinetic data</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Weight on Volume of Distribution (V/F) of Dabrafenib Estimated With a PopPK Model</title>
          <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on volume of distribution (V/F) of dabrafenib estimated with the PopPK model is summarized in this record.</description>
          <population>All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. All trametinib and dabrafenib concentration-time data were combined and included in a population PK analysis that examined the influence of demographics on the PK of study treatment.</population>
          <units>coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.593"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Weight on Absorption Rate (ka) of Dabrafenib Estimated With a PopPK Model</title>
        <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on absorption rate (ka) of dabrafenib estimated with a PopPK model is summarized in this record.</description>
        <time_frame>Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.</time_frame>
        <population>All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. The covariate weight did not meet the pre-specified criteria to be considered a significant covariate on Ka based on the goodness-of-fit plots and the decrease of the objective function provided by the PopPK software (NONMEM). Therefore, effect of weight on Ka could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 and Part 2 - All Participants With PK Data</title>
            <description>Participants in the study (all doses and all tumor types) with available pharmacokinetic data</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Weight on Absorption Rate (ka) of Dabrafenib Estimated With a PopPK Model</title>
          <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on absorption rate (ka) of dabrafenib estimated with a PopPK model is summarized in this record.</description>
          <population>All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. The covariate weight did not meet the pre-specified criteria to be considered a significant covariate on Ka based on the goodness-of-fit plots and the decrease of the objective function provided by the PopPK software (NONMEM). Therefore, effect of weight on Ka could not be calculated.</population>
          <units>coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">N/A: covariate weight did not meet the pre-specified criteria required to calculate a result in the PopPK model</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effect of Weight on Coefficients for Significant Covariates of Dabrafenib Estimated With a PopPK Model</title>
        <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on coefficients for significant covariates of dabrafenib estimated with a PopPK model is summarized in this record.</description>
        <time_frame>Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.</time_frame>
        <population>All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. The covariate weight did not meet the pre-specified criteria to be considered a significant covariate based on the goodness-of-fit plots and the decrease of the objective function provided by the PopPK software (NONMEM). Therefore, effect of weight on coefficients for significant covariates of dabrafenib could not be calculated.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 and Part 2 - All Participants With PK Data</title>
            <description>Participants in the study (all doses and all tumor types) with available pharmacokinetic data</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Weight on Coefficients for Significant Covariates of Dabrafenib Estimated With a PopPK Model</title>
          <description>The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on coefficients for significant covariates of dabrafenib estimated with a PopPK model is summarized in this record.</description>
          <population>All subjects who received at least one dose of dabrafenib in Part 1 and 2 and provided an evaluable PK profile. The covariate weight did not meet the pre-specified criteria to be considered a significant covariate based on the goodness-of-fit plots and the decrease of the objective function provided by the PopPK software (NONMEM). Therefore, effect of weight on coefficients for significant covariates of dabrafenib could not be calculated.</population>
          <units>coefficient</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">N/A: covariate weight did not meet the pre-specified criteria required to calculate a result in the PopPK model</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>All Collected Deaths in Parts I and II</title>
        <description>On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).&#xD;
Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 7 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.</description>
        <time_frame>up to 360 weeks (on-treatment in Part I), up to 300 weeks (on-treatment in Part II), up to approximately 7 years (study duration)</time_frame>
        <population>Clinical database population; all treated patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O2">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O3">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O4">
            <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
            <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
          </group>
          <group group_id="O5">
            <title>Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)</title>
            <description>Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
          <group group_id="O6">
            <title>Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)</title>
            <description>Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
          <group group_id="O7">
            <title>Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)</title>
            <description>Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
          <group group_id="O8">
            <title>Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)</title>
            <description>Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
          </group>
        </group_list>
        <measure>
          <title>All Collected Deaths in Parts I and II</title>
          <description>On treatment deaths were collected from FPFT up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).&#xD;
Deaths post treatment survival follow up were collected after the on- treatment period, up to approximately 7 years. Patients who didn't die during the on-treatment period and had not stopped study participation at the time of data cut-off (end of study) were censored.</description>
          <population>Clinical database population; all treated patients.</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="3"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="28"/>
                <count group_id="O7" value="11"/>
                <count group_id="O8" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>On-treatment deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-treatment deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="1"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from First Patient First Treatment (FPFT) up to 28 days after study drug discontinuation, for a maximum duration of 360 weeks in Part I (treatment duration ranged from 5.6 to 356.0 weeks) and a maximum duration of 300 weeks in Part II (treatment duration ranged from 0.3 to 296.0 weeks).</time_frame>
      <desc>Any sign or symptom that occurs during the treatment period plus 28 days post-treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="E2">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (3.75 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="E3">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (4.5 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="E4">
          <title>Part 1 (Dose Escalation): Dabrafenib Treatment (5.25 mg/kg)</title>
          <description>Repeat dose, dose escalation study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6 Design (RSD). The RSD was built on the classic 3+3 design, but allowed for continued recruitment of subjects while the data from the first 3 subjects in each cohort was collected (up to 6 subjects per cohort). The starting dose was 3 mg/kg with subsequent dose levels: 3.75 mg/kg, 4.5 mg/kg, 5.25 mg/kg and 6.0 mg/kg.</description>
        </group>
        <group group_id="E5">
          <title>Part 2 (Tumor Specific Expansion): Cohort 1 Low-Grade Gliomas (LGG)</title>
          <description>Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="E6">
          <title>Part 2 (Tumor Specific Expansion): Cohort 2 High-Grade Gliomas (HGG)</title>
          <description>Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="E7">
          <title>Part 2 (Tumor Specific Expansion): Cohort 3 Langerhans Cell Histiocytosis (LCH)</title>
          <description>Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
        <group group_id="E8">
          <title>Part 2 (Tumor Specific Expansion): Cohort 4 Miscellaneous Tumors (Other)</title>
          <description>Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="13" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Corynebacterium infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pseudomonal bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Salmonellosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Shunt malfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Stroke-like migraine attacks after radiation therapy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood culture positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Epstein-Barr virus associated lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tumour haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Meningeal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis bullous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pityriasis rosea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="17" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="26" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="11" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Monocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neutrophilia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cardiac disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tricuspid valve disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Deafness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>External ear inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Precocious puberty</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Blepharospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dark circles under eyes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypermetropia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Optic nerve disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Papilloedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Periorbital swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Retinal exudates</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Scleral disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vernal keratoconjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Chapped lips</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cheilosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Duodenal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Duodenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral mucosal eruption</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="9" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Catheter site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Catheter site extravasation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Localised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Candida infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Carbuncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Coronavirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Enterobiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Enterovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Groin abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Metapneumovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pertussis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pitted keratolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pustule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin bacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Streptococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tinea cruris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tinea infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tracheostomy infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vascular device infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Viral rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vulval abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vulvovaginal candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Animal scratch</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Clavicle fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gastrostomy tube site complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nail avulsion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Scar</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Activated partial thromboplastin time prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood bilirubin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood calcium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood chloride increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood creatinine decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood fibrinogen decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood luteinising hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood prolactin abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blood urea decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Carbon dioxide decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Creatinine urine decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Low density lipoprotein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Protein total increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Protein urine present</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Red blood cell count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory rate decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urine albumin/creatinine ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urine analysis abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urine protein/creatinine ratio increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Folate deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperchloraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypermagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Iron deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Polydipsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vitamin B12 deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ligament pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Limb mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Muscle contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Musculoskeletal deformity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acrochordon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lip neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Xanthogranuloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </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_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ataxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysmetria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Facial nerve disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hemianopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypersomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Muscle spasticity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nystagmus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oculofacial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Partial seizures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Periodic limb movement disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Psychomotor hyperactivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>VIth nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Aggression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Anger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Attention deficit hyperactivity disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysphemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Emotional disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Middle insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Haemoglobinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Microalbuminuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Renal tubular disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Adenoidal hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Catarrh</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypocapnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Laryngeal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Restrictive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Cafe au lait spots</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis bullous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis diaper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative generalised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="9" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Eczema asteatotic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ephelides</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Erythema nodosum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hair colour changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hair texture abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hidradenitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Ingrown hair</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Keloid scar</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Keratosis pilaris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Lentigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Macule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nail discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Nail pigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Neurodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Onychomadesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Palmoplantar keratoderma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Panniculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Photosensitivity reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Rash vesicular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Scab</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Seborrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin fissures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin induration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Skin odour abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Xeroderma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Yellow skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Steroid therapy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="2"/>
              </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 (ie, 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/NCT01677741
org study id: 116013
secondary id: 2012-001499-12
secondary id: CDRB436A2102
nct id: NCT01677741
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This was a 2-part, Phase I/IIa, multi-center, open label, study in pediatric and adolescent
      patients with advanced BRAF V600 mutation-positive solid tumors. Part 1 was a dose escalation
      study in patients with any BRAF V600 mutation-positive solid tumor using a modified Rolling 6
      Design (RSD). Part 2 was an expansion study to further evaluate the safety, tolerability, and
      clinical activity of dabrafenib in 4 tumor-specific pediatric populations. Patients
      participated in only either part 1 or part 2 of the study.
Part 1 was a dose escalation study in subjects with any BRAF V600 mutation-positive solid
      tumor, designed to optimize efficiency of enrollment, minimize the number of subjects being
      treated at potentially sub-efficacious dose levels, and incorporating the evolving
      pharmacokinetic, safety and efficacy data from the adult development program. Dose escalation
      part of the study was to determine the maximum tolerated dose (MTD) and recommend the dose
      for phase 2 studies (RP2D). An MTD has not been identified for dabrafenib in the adult
      population. This does not preclude the identification of an MTD in the pediatric population.
      Modified RSD was employed to determine the MTD. Part 1 used dual criteria of dose limiting
      toxicity (DLT) and observed dabrafenib exposures to make decisions to advance to the next
      dose level. Target exposure criteria based on adults treated at the approved adult dose of
      300 mg (150 mg given BID) were observed in this study before meeting criteria for stopping
      dose escalation due to observations of DLTs, and served as the criteria for determining the
      RP2D for dabrafenib in pediatric subjects. Thus, MTD has not been established in pediatric
      population, similar to the previous dose finding efforts in adult subjects.

      Part 2 was a tumor specific expansion study to further evaluate the safety/tolerability
      profile and to discover possible clinical efficacy of dabrafenib in 4 tumor-specific
      pediatric populations known to have BRAFV600 activation: high grade glioma (HGG), low grade
      glioma (LGG), Langerhans cell histiocytosis (LCH), miscellaneous tumors including melanoma
      and papillary thyroid carcinoma (Other). The exposures for subjects dosed on the basis of
      weight were also evaluated by age categories.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment Emergent Adverse Events (AEs) in Part 1 (Dose Escalation)
time frame: From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months
description: The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Events and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters. Only descriptive analysis performed.
measure: Maximum Concentration (Cmax) of Dabrafenib
time frame: Week 1 Day 1, Week 3 Day 15
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib was listed and summarized using descriptive statistics.
measure: Area Under the Concentration-time Curve Over the Dosing Interval (AUC(0-τ)) and AUC From Zero to Infinity (AUC(0-inf)) of Dabrafenib
time frame: Week 1 Day 1
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. AUC(0-τ) and AUC(0-inf) of dabrafenib were to be listed and summarized using descriptive statistics.
measure: Pre-dose (Trough) Concentration (C Tau) of Dabrafenib and Its Metabolites
time frame: Week 3 Day 15
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Pre-dose (trough) concentration (C tau) was to be listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).
measure: The AUC(0-t) of Dabrafenib Metabolites
time frame: Week 1 Day 1, Week 3 Day 15
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC[0-t]) dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.
measure: The AUC(0-tau) of Dabrafenib and Its Metabolites
time frame: Week 1 Day 1, Week 3 Day 15
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Area under the time-concentration curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-tau) of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were to be listed and summarized using descriptive statistics.
measure: Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) of Dabrafenib
time frame: Week 1 Day 1, Week 3 Day 15
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. CL/F of dabrafenib was to be listed and summarized using descriptive statistics.
measure: Maximum Concentration (Cmax) of Dabrafenib Metabolites
time frame: Week 1 Day 1, Week 3 Day 15
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax of dabrafenib metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) were listed and summarized using descriptive statistics.
measure: Time to Reach Maximum (Peak) Plasma Concentration Following Drug Administration (Tmax) of Dabrafenib and Its Metabolites
time frame: Week 1 Day 1, Week 3 Day 15
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics for dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]).
measure: Elimination Half Life (T½) of Dabrafenib and Its Metabolites
time frame: Week 3 Day 15
description: Venous whole blood samples were collected for activity-based pharmacokinetics characterization. T1/2 of dabrafenib and its metabolites (hydroxy-dabrafenib [GSK2285403], carboxy-dabrafenib [GSK2298683], and desmethyl-dabrafenib [GSK2167542]) was listed and summarized using descriptive statistics.
measure: Incidence of Treatment Emergent Adverse Events (AEs) in Part 2 (Tumor Specific Expansion)
time frame: From study treatment start date till 28 days safety follow-up, assessed up to approximately 90 months
description: The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Events, Serious Adverse Event and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
measure: Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for Low Grade Glioma (LLG) Subjects
time frame: Up to 6 months
description: Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.
measure: Best Overall Response Based on Investigator Assessment Per Response Assessment in Neuro-Oncology (RANO) Criteria for High Grade Glioma (HGG) Subjects
time frame: Up to 6 months
description: Overall Response Rate (ORR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR).based on Response Assessment in Neuro-Oncology (RANO) criteria for Low Grade Glioma (LLG) and High Grade Glioma (HGG) subjects.
measure: Effect of Weight on Total Apparent Clearance (CL/F) of Dabrafenib Estimated With a PopPK Model
time frame: Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.
description: The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on total apparent clearance (CL/F) of dabrafenib estimated with the PopPK model is summarized in this record.
measure: Effect of Weight on Volume of Distribution (V/F) of Dabrafenib Estimated With a PopPK Model
time frame: Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.
description: The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on volume of distribution (V/F) of dabrafenib estimated with the PopPK model is summarized in this record.
measure: Effect of Weight on Absorption Rate (ka) of Dabrafenib Estimated With a PopPK Model
time frame: Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.
description: The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on absorption rate (ka) of dabrafenib estimated with a PopPK model is summarized in this record.
measure: Effect of Weight on Coefficients for Significant Covariates of Dabrafenib Estimated With a PopPK Model
time frame: Day 1-Predose, 0.5, 2 and 4 hours post dose; Day 15-Predose, 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose.
description: The population pharmacokinetic (PopPK) model of Dabrafenib can be described using a two-compartment model with a delayed 1st order absorption (Alag1, Ka) and an inducible elimination (CL/F) that consists of a base clearance (constant over time, CL0/F) and a dose- and time-dependent inducible clearance (CLind/F). The PopPK analysis examined the influence of demographics (i.e., weight) on the pharmacokinetics of dabrafenib. The effect of weight on coefficients for significant covariates of dabrafenib estimated with a PopPK model is summarized in this record.
arm group label: Part 1: Dabrafenib treatment
arm group type: Experimental
description: Three subjects will receive a single dose of 3 mg/kg dabrafenib on Day 1 and repeat dose will begin from Day 2, evenly divided in two daily doses. Once all 3 subjects have been fully evaluated for the first 28 days (including Day 15 PK) and no DLTs are observed, a next subject will be enrolled at the next higher dose levels (i.e., dose escalation to 3.75 mg/kg [+1] and may be further to 4.5 mg/kg [+2] and so on). If all 3 subjects have not been fully evaluated for the first 28 days or 1 DLT occurred, the fourth subject will be enrolled at the same dose level. If 2 or more DLTs are observed, the next subject will be enrolled at the next lower dose level (i.e., de-escalated to 2.25 mg/kg [-1] and may be further to 1.5 mg/kg [-2]). Similarly, the process is repeated for the fifth and sixth subjects in a cohort. All subjects will receive treatment till end of study.
arm group label: Part 2: Cohort 1 Low-Grade Gliomas with BRAF V600 mutations
arm group type: Experimental
description: Subjects with low-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
arm group label: Part 2: Cohort 2 High-Grade Gliomas with BRAF V600 mutations
arm group type: Experimental
description: Subjects with high-grade gliomas with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
arm group label: Part 2: Cohort 3 LCH with BRAF V600 mutations
arm group type: Experimental
description: Subjects with LCH with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
arm group label: Part 2: Cohort 4 Melanoma and PTC with BRAF V600 mutations
arm group type: Experimental
description: Subjects with other tumors with BRAF V600 mutations will receive the single selected final dose (based on MTD and the age of the subjects) from Part 1 on Day 1. Repeat dosing will begin from Day 2, twice daily till end of study.
intervention type: Drug
intervention name: Dabrafenib
description: Dabrafenib is available as 50 mg or 75 mg capsules and as oral suspension (10 mg/mL for subjects unable to swallow capsules). Dabrafenib (either formulation) will be administered orally as a single dose on Day 1 and twice daily from Day 2, based on weight at the appropriate study dose level.
arm group label: Part 1: Dabrafenib treatment
arm group label: Part 2: Cohort 1 Low-Grade Gliomas with BRAF V600 mutations
arm group label: Part 2: Cohort 2 High-Grade Gliomas with BRAF V600 mutations
arm group label: Part 2: Cohort 3 LCH with BRAF V600 mutations
arm group label: Part 2: Cohort 4 Melanoma and PTC with BRAF V600 mutations
other name: DRB436
criteria: 
gender: All
minimum age: 12 Months
maximum age: 17 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: Canada
country: Denmark
country: France
country: Germany
country: Israel
country: Italy
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Brain Neoplasms
mesh term: Dabrafenib
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: 