<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/NCT01719380</url>
  </required_header>
  <id_info>
    <org_study_id>CLGX818X2103</org_study_id>
    <secondary_id>C4221002</secondary_id>
    <secondary_id>2012-002138-35</secondary_id>
    <nct_id>NCT01719380</nct_id>
  </id_info>
  <brief_title>Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer</brief_title>
  <official_title>A Phase Ib/II Multi-center, Open-label, Dose Escalation Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in Patients With BRAF Mutant Metastatic Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      This study will assess the safety and efficacy of LGX818 when combined with cetuximab or&#xD;
      combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 23, 2012</start_date>
  <completion_date type="Actual">February 12, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 2015</primary_completion_date>
  <phase>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>Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1</measure>
    <time_frame>Cycle 1: Day 1 to Day 28</time_frame>
    <description>DLTs were defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment and meets any of the criteria included blood and lymphatic system disorders, investigations (blood, renal, hepatic, metabolic), skin and subcutaneous tissue disorders: rash, HFSR (hand foot skin reaction) and/or photosensitivity, metabolism and nutrition disorders: hyperglycemia, gastrointestinal disorders, cardiac disorders, vascular disorders, general disorders and administration site conditions, tumor lysis syndrome, ophthalmologic and other adverse events: study drug-related fever, alkaline phosphatase elevation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Progression Free Survival (PFS)</measure>
    <time_frame>From the date of randomization until the first documentation of disease progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)</time_frame>
    <description>PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. Participants who did not progress per RECIST (Response Evaluation Criteria in Solid Tumors) version (v) 1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment - Emergent Adverse Events of Grade 3 or 4 Severity Based on National Cancer Institute of Common Terminology Criteria (NCI-CTCAE), Version 4.0</measure>
    <time_frame>From screening up to 30 days after the last dose of study treatment (for a maximum duration of 43 months, approximately)</time_frame>
    <description>An AE was any untoward medical occurrence attributed to study drug in participants who received study drug. As per NCI-CTCAE v4.0, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to study drug. Treatment-emergent AEs are between first dose of study drug and up to 30 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. Number of participants with any Grade 3 or 4 treatment-emergent AE were reported in this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Plasma Clearance (CL/F) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Plasma Clearance at Steady State (CL/F, ss) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Plasma Clearance (CL/F) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Plasma Clearance at Steady State (CL/F, ss) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Volume of Distribution (Vz/F) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Volume of distribution at steady state is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Volume of Distribution (Vz/F) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Tmax was defined as the time to reach maximum observed plasma concentration of encorafenib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Tmax, ss was defined as the time to reach maximum observed plasma concentration of LGX818 (encorafenib) at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Tmax was defined as the time to reach maximum observed plasma concentration of alpelisib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Tmax, ss was defined as the time to reach maximum observed plasma concentration of BYL719 (alpelisib) at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Last Observed Plasma Concentration (T-last) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>T-last was defined as the time to reach last observed plasma concentration of encorafenib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>T-last, ss was defined as the time to reach last observed plasma concentration of encorafenib at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Last Observed Plasma Concentration (T-last) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>T-last was defined as the time to reach last observed plasma concentration of alpelisib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>T-last, ss was defined as the time to reach last observed plasma concentration of alpelisib at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Trough Concentration at Steady State (Ctrough, ss) of LGX818 (Encorafenib)</measure>
    <time_frame>Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Ctrough, ss was defined as plasma trough concentration of encorafenib at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Trough Concentration at Steady State (Ctrough, ss) of BYL719 (Alpelisib)</measure>
    <time_frame>Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
    <description>Ctrough, ss was defined as plasma trough concentration of alpelisib at steady state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first (up to 43 months)</time_frame>
    <description>OS was defined as the time (in months) from the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause (maximum up to 43 months)</time_frame>
    <description>Overall response rate as assessed by the investigator per RECIST v1.1, was defined as percentage of participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-nodal target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Only confirmed CR and PR are counted (those confirmed at least 4 weeks).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>From the first documentation of OR (confirmed CR or PR) to first documentation of PD/death due to any cause or censoring date, whichever occurred first (up to 43 months)</time_frame>
    <description>DOR: Time between date of the first documented response (CR or PR) and the date of first documented PD or death due to underlying cancer. If PD or death due to underlying cancer not occurred, then participant was censored at the date of last tumor assessment other than unknown. DOR was calculated for responders (confirmed) only. CR: Disappearance of all target, non-target lesions sustained for &gt;=4 weeks and any pathological lymph nodes reduced in short axis to &lt;10mm. PR: &gt;=30% decrease in sum of diameters of target lesions, taking as reference baseline sum of diameter. PD for target lesions: At least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment, with absolute increase of &gt;=5 mm, or appearance of &gt;=1 new lesions. PD for non-target lesions: Unequivocal progression of pre-existing lesions/increase in overall tumor burden leading to discontinuation of therapy or appearance of new unequivocal malignant lesion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR)</measure>
    <time_frame>From the date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first (maximum up to 43 months)</time_frame>
    <description>TTR as assessed by investigator according to RECIST v1.1, was defined as the time (in months) from date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to &lt;10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b: Progression Free Survival (PFS)</measure>
    <time_frame>From date of start of treatment to the date of event defined as the first documented progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)</time_frame>
    <description>PFS was defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. Participants who did not progress per RECIST v1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Number of Participants With Any Variant in Gene Status at Baseline</measure>
    <time_frame>Baseline (Day 1)</time_frame>
    <description>Gene alterations/expression relevant to the RAF/MEK/ERK (proto-oncogene serine/threonine-protein kinase/ mitogen-activated ERK kinase/ extracellular signal-regulated kinases) and EGFR/PI3K/AKT (epidermal growth factor receptor/ phosphatidylinositol 3-kinase/ protein kinase B) pathways in tumor tissue, baseline molecular status (mutation/amplification/expression) in tumor tissue of potential predictive markers of tumor response or resistance i.e. BRAF (v-raf murine sarcoma viral oncogene homolog B1), HRAS (harvey rat sarcoma protein), KRAS (V-Ki-ras2 kirsten rat sarcoma viral oncogene homolog B1), NRAS (neuroblastoma RAS viral oncogene homolog), PTEN (phosphatase and tensin homolog), PIK3CA (phosphatidylinositol 3-kinase gene), MAP2K1 (mitogen-activated protein kinase 1), MAP2K2 (mitogen-activated protein kinase 2), ARAF, c-MET, RAF1, EGFR was analyzed.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>LGX818 + cetuximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>LGX818 + BYL719 + cetuximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LGX818</intervention_name>
    <arm_group_label>LGX818 + BYL719 + cetuximab</arm_group_label>
    <arm_group_label>LGX818 + cetuximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cetuximab</intervention_name>
    <arm_group_label>LGX818 + BYL719 + cetuximab</arm_group_label>
    <arm_group_label>LGX818 + cetuximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BYL719</intervention_name>
    <arm_group_label>LGX818 + BYL719 + cetuximab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Metastatic colorectal cancer&#xD;
&#xD;
          -  Progression after at least one prior standard of care regimen or be intolerant to&#xD;
             irinotecan-based regimens&#xD;
&#xD;
          -  Life expectancy ≥ 3 months&#xD;
&#xD;
          -  ECOG performance status ≤ 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic or untreated leptomeningeal disease&#xD;
&#xD;
          -  Symptomatic brain metastasis&#xD;
&#xD;
          -  Patients with clinically manifested diabetes&#xD;
&#xD;
          -  Acute or chronic pancreatitis&#xD;
&#xD;
          -  Clinically significant cardiac disease&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Keck Hospital of USC</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LAC&amp;USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC/Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westwood Bowyer Clinic, Peter Morton Medical Building</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology Oncology</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Santa Monica Medical Center &amp; Orthopaedic Hospital</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Hospital at Yale-New Haven</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smilow Cancer Hospital Care Center at North Haven</name>
      <address>
        <city>North Haven</city>
        <state>Connecticut</state>
        <zip>06473</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114-2620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017-6706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Dickson</city>
        <state>Tennessee</state>
        <zip>37055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <zip>37067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Gallatin</city>
        <state>Tennessee</state>
        <zip>37066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Hermitage</city>
        <state>Tennessee</state>
        <zip>37076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Lebanon</city>
        <state>Tennessee</state>
        <zip>37909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Murfreesboro</city>
        <state>Tennessee</state>
        <zip>37129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Shelbyville</city>
        <state>Tennessee</state>
        <zip>37160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology, PLLC</name>
      <address>
        <city>Smyrna</city>
        <state>Tennessee</state>
        <zip>37167</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah - Huntsman Cancer Institute - PPDS</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112-5550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Redwood Health Center - ARUP Lab Draw Location</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John A Moran Eye Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Mortimer B. Davis Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Régional de Lutte Contre Le Cancer Val D'aurelle Paul Lamarque</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EDOG - Institut Claudius Regaud - PPDS</name>
      <address>
        <city>Toulouse</city>
        <zip>31052</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Koln</name>
      <address>
        <city>Köln</city>
        <state>Nordrhein-westfalen</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedaliero Universitaria di Modena Policlinico</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacy of National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center - PPDS</name>
      <address>
        <city>Gangnam-Gu</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center - PPDS</name>
      <address>
        <city>Songpa-Gu</city>
        <state>Seoul Teugbyeolsi</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-holland</state>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid-holland</state>
        <zip>3015 CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Utrecht</name>
      <address>
        <city>Utrecht</city>
        <zip>3584 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oslo Myeloma Center - PPDS</name>
      <address>
        <city>Oslo</city>
        <zip>0379</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigacion Oncologica Vall d'Hebron (VHIO) - EPON</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio - PPDS</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>April 12, 2021</results_first_submitted>
  <results_first_submitted_qc>May 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2021</results_first_posted>
  <disposition_first_submitted>July 17, 2017</disposition_first_submitted>
  <disposition_first_submitted_qc>July 17, 2017</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">July 19, 2017</disposition_first_posted>
  <last_update_submitted>May 26, 2021</last_update_submitted>
  <last_update_submitted_qc>May 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Open-label dose escalation</keyword>
  <keyword>BRAF inhibitor</keyword>
  <keyword>LGX818</keyword>
  <keyword>PI3K inhibitor</keyword>
  <keyword>BYL719</keyword>
  <keyword>EGFR</keyword>
  <keyword>cetuximab</keyword>
  <keyword>metastatic colorectal cancer</keyword>
  <keyword>KRAS</keyword>
  <keyword>BRAF</keyword>
  <keyword>V600</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cetuximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This study was conducted in two phases Phase 1b and Phase 2. Phase 1b of the study was dose escalation phase to determine maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of LGX818 in combination with cetuximab (dual combination) and of LGX818 in combination with BYL719 and cetuximab (triple combination). Phase 2 of the study was to determine the clinical efficacy and safety of dual and triple combination in study participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
          <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P2">
          <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P3">
          <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
          <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P4">
          <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
          <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P5">
          <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P6">
          <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P7">
          <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P8">
          <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
          <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P9">
          <title>Phase 2: LGX818 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="P10">
          <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="7"/>
                <participants group_id="P9" count="50"/>
                <participants group_id="P10" count="52"/>
              </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 group_id="P9" count="0"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="7"/>
                <participants group_id="P9" count="50"/>
                <participants group_id="P10" count="51"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="1"/>
                <participants group_id="P9" count="4"/>
                <participants group_id="P10" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="3"/>
                <participants group_id="P10" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant/Guardian Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="2"/>
                <participants group_id="P10" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="7"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="39"/>
                <participants group_id="P10" count="42"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
                <participants group_id="P10" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
          <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B2">
          <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B3">
          <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
          <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B4">
          <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
          <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B5">
          <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B6">
          <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B7">
          <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B8">
          <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
          <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B9">
          <title>Phase 2: LGX818 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B10">
          <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="B11">
          <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="2"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="9"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="3"/>
            <count group_id="B6" value="8"/>
            <count group_id="B7" value="10"/>
            <count group_id="B8" value="7"/>
            <count group_id="B9" value="50"/>
            <count group_id="B10" value="52"/>
            <count group_id="B11" value="156"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="8"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="32"/>
                    <measurement group_id="B10" value="38"/>
                    <measurement group_id="B11" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="4"/>
                    <measurement group_id="B7" value="2"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="18"/>
                    <measurement group_id="B10" value="14"/>
                    <measurement group_id="B11" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="5"/>
                    <measurement group_id="B9" value="36"/>
                    <measurement group_id="B10" value="27"/>
                    <measurement group_id="B11" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                    <measurement group_id="B7" value="3"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="14"/>
                    <measurement group_id="B10" value="25"/>
                    <measurement group_id="B11" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1</title>
        <description>DLTs were defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment and meets any of the criteria included blood and lymphatic system disorders, investigations (blood, renal, hepatic, metabolic), skin and subcutaneous tissue disorders: rash, HFSR (hand foot skin reaction) and/or photosensitivity, metabolism and nutrition disorders: hyperglycemia, gastrointestinal disorders, cardiac disorders, vascular disorders, general disorders and administration site conditions, tumor lysis syndrome, ophthalmologic and other adverse events: study drug-related fever, alkaline phosphatase elevation.</description>
        <time_frame>Cycle 1: Day 1 to Day 28</time_frame>
        <population>The dose-determining set consisted of all participants from the phase 1b safety set who either met the following minimum exposure criterion and had scheduled safety evaluations or discontinued earlier due to DLT.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1</title>
          <description>DLTs were defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment and meets any of the criteria included blood and lymphatic system disorders, investigations (blood, renal, hepatic, metabolic), skin and subcutaneous tissue disorders: rash, HFSR (hand foot skin reaction) and/or photosensitivity, metabolism and nutrition disorders: hyperglycemia, gastrointestinal disorders, cardiac disorders, vascular disorders, general disorders and administration site conditions, tumor lysis syndrome, ophthalmologic and other adverse events: study drug-related fever, alkaline phosphatase elevation.</description>
          <population>The dose-determining set consisted of all participants from the phase 1b safety set who either met the following minimum exposure criterion and had scheduled safety evaluations or discontinued earlier due to DLT.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Progression Free Survival (PFS)</title>
        <description>PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. Participants who did not progress per RECIST (Response Evaluation Criteria in Solid Tumors) version (v) 1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.</description>
        <time_frame>From the date of randomization until the first documentation of disease progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)</time_frame>
        <population>The full analysis set 2 (FAS2) comprised of all participants to whom study treatment was assigned by randomization.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Progression Free Survival (PFS)</title>
          <description>PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. Participants who did not progress per RECIST (Response Evaluation Criteria in Solid Tumors) version (v) 1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.</description>
          <population>The full analysis set 2 (FAS2) comprised of all participants to whom study treatment was assigned by randomization.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" lower_limit="3.0" upper_limit="5.1"/>
                    <measurement group_id="O2" value="4.9" lower_limit="4.0" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment - Emergent Adverse Events of Grade 3 or 4 Severity Based on National Cancer Institute of Common Terminology Criteria (NCI-CTCAE), Version 4.0</title>
        <description>An AE was any untoward medical occurrence attributed to study drug in participants who received study drug. As per NCI-CTCAE v4.0, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to study drug. Treatment-emergent AEs are between first dose of study drug and up to 30 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. Number of participants with any Grade 3 or 4 treatment-emergent AE were reported in this outcome measure.</description>
        <time_frame>From screening up to 30 days after the last dose of study treatment (for a maximum duration of 43 months, approximately)</time_frame>
        <population>The safety set included all participants from the full analysis set who received at least 1 dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least 1 valid post baseline safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment - Emergent Adverse Events of Grade 3 or 4 Severity Based on National Cancer Institute of Common Terminology Criteria (NCI-CTCAE), Version 4.0</title>
          <description>An AE was any untoward medical occurrence attributed to study drug in participants who received study drug. As per NCI-CTCAE v4.0, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to study drug. Treatment-emergent AEs are between first dose of study drug and up to 30 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. Number of participants with any Grade 3 or 4 treatment-emergent AE were reported in this outcome measure.</description>
          <population>The safety set included all participants from the full analysis set who received at least 1 dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least 1 valid post baseline safety assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="50"/>
                <count group_id="O10" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="5"/>
                    <measurement group_id="O7" value="7"/>
                    <measurement group_id="O8" value="6"/>
                    <measurement group_id="O9" value="33"/>
                    <measurement group_id="O10" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Total Plasma Clearance (CL/F) of LGX818 (Encorafenib)</title>
        <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
        <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least one blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Plasma Clearance (CL/F) of LGX818 (Encorafenib)</title>
          <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
          <population>The PK analysis set consisted of all participants who had at least one blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="15"/>
                <count group_id="O10" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="3.60"/>
                    <measurement group_id="O2" value="11.7" spread="6.10"/>
                    <measurement group_id="O3" value="12.1" spread="5.95"/>
                    <measurement group_id="O4" value="12.3" spread="4.96"/>
                    <measurement group_id="O5" value="7.69" spread="3.13"/>
                    <measurement group_id="O6" value="14.2" spread="5.75"/>
                    <measurement group_id="O7" value="14.1" spread="3.65"/>
                    <measurement group_id="O8" value="17.8" spread="17.4"/>
                    <measurement group_id="O9" value="13.1" spread="5.07"/>
                    <measurement group_id="O10" value="10.9" spread="5.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Total Plasma Clearance at Steady State (CL/F, ss) of LGX818 (Encorafenib)</title>
        <description>Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
        <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least one blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Plasma Clearance at Steady State (CL/F, ss) of LGX818 (Encorafenib)</title>
          <description>Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
          <population>The PK analysis set consisted of all participants who had at least one blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
          <units>liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="28"/>
                <count group_id="O10" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="17.0" spread="3.42"/>
                    <measurement group_id="O6" value="24.4" spread="18.3"/>
                    <measurement group_id="O7" value="15.4" spread="4.25"/>
                    <measurement group_id="O8" value="22.4" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 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="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="7"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="10"/>
                    <count group_id="O10" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9" spread="4.72"/>
                    <measurement group_id="O2" value="31.1" spread="11.9"/>
                    <measurement group_id="O3" value="31.6" spread="2.19"/>
                    <measurement group_id="O4" value="30.5" spread="12.3"/>
                    <measurement group_id="O5" value="32.6" spread="6.88"/>
                    <measurement group_id="O6" value="20.2" spread="7.91"/>
                    <measurement group_id="O7" value="22.7" spread="5.68"/>
                    <measurement group_id="O8" value="38.4" spread="16.4"/>
                    <measurement group_id="O9" value="28.2" spread="8.97"/>
                    <measurement group_id="O10" value="23.3" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Total Plasma Clearance (CL/F) of BYL719 (Alpelisib)</title>
        <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
        <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Plasma Clearance (CL/F) of BYL719 (Alpelisib)</title>
          <description>Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" spread="2.03"/>
                    <measurement group_id="O2" value="12.1" spread="3.96"/>
                    <measurement group_id="O3" value="11.6" spread="1.85"/>
                    <measurement group_id="O4" value="11.7" spread="5.38"/>
                    <measurement group_id="O5" value="15.6" spread="9.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Total Plasma Clearance at Steady State (CL/F, ss) of BYL719 (Alpelisib)</title>
        <description>Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
        <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Total Plasma Clearance at Steady State (CL/F, ss) of BYL719 (Alpelisib)</title>
          <description>Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
          <units>liter per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.5" spread="5.96"/>
                    <measurement group_id="O2" value="13.2" spread="2.29"/>
                    <measurement group_id="O3" value="13.7" spread="7.20"/>
                    <measurement group_id="O4" value="11.6" spread="6.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 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="4"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" spread="0.794"/>
                    <measurement group_id="O2" value="10.3" spread="1.23"/>
                    <measurement group_id="O3" value="12.5" spread="1.60"/>
                    <measurement group_id="O4" value="19.0" spread="6.51"/>
                    <measurement group_id="O5" value="17.9" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Volume of Distribution (Vz/F) of LGX818 (Encorafenib)</title>
        <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
        <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Volume of Distribution (Vz/F) of LGX818 (Encorafenib)</title>
          <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="15"/>
                <count group_id="O10" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104" spread="28.3"/>
                    <measurement group_id="O2" value="60.3" spread="25.8"/>
                    <measurement group_id="O3" value="62.8" spread="31.8"/>
                    <measurement group_id="O4" value="57.2" spread="29.6"/>
                    <measurement group_id="O5" value="49.2" spread="12.4"/>
                    <measurement group_id="O6" value="75.7" spread="31.6"/>
                    <measurement group_id="O7" value="64.6" spread="20.6"/>
                    <measurement group_id="O8" value="60.7" spread="44.0"/>
                    <measurement group_id="O9" value="63.5" spread="29.9"/>
                    <measurement group_id="O10" value="80.9" spread="93.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of LGX818 (Encorafenib)</title>
        <description>Volume of distribution at steady state is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.</description>
        <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of LGX818 (Encorafenib)</title>
          <description>Volume of distribution at steady state is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
          <units>liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="28"/>
                <count group_id="O10" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="78.4" spread="13.0"/>
                    <measurement group_id="O6" value="98.2" spread="84.5"/>
                    <measurement group_id="O7" value="78.6" spread="26.2"/>
                    <measurement group_id="O8" value="88.8" spread="53.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 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="4"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="6"/>
                    <count group_id="O7" value="7"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="10"/>
                    <count group_id="O10" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.8" spread="13.7"/>
                    <measurement group_id="O2" value="131" spread="45.8"/>
                    <measurement group_id="O3" value="110" spread="41.1"/>
                    <measurement group_id="O4" value="142" spread="84.5"/>
                    <measurement group_id="O5" value="137" spread="32.9"/>
                    <measurement group_id="O6" value="91.6" spread="41.4"/>
                    <measurement group_id="O7" value="102" spread="39.9"/>
                    <measurement group_id="O8" value="187" spread="89.5"/>
                    <measurement group_id="O9" value="117" spread="37.6"/>
                    <measurement group_id="O10" value="105" spread="42.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Volume of Distribution (Vz/F) of BYL719 (Alpelisib)</title>
        <description>Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
        <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Volume of Distribution (Vz/F) of BYL719 (Alpelisib)</title>
          <description>Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>liter</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="5"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="4"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112" spread="22.0"/>
                    <measurement group_id="O2" value="104" spread="31.0"/>
                    <measurement group_id="O3" value="105" spread="34.3"/>
                    <measurement group_id="O4" value="106" spread="78.6"/>
                    <measurement group_id="O5" value="123" spread="50.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of BYL719 (Alpelisib)</title>
        <description>Volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.</description>
        <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of BYL719 (Alpelisib)</title>
          <description>Volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
          <units>liter</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="8"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110" spread="40.7"/>
                    <measurement group_id="O2" value="97.0" spread="20.6"/>
                    <measurement group_id="O3" value="105" spread="30.2"/>
                    <measurement group_id="O4" value="82.5" spread="18.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 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="4"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="2"/>
                    <count group_id="O5" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138" spread="20.7"/>
                    <measurement group_id="O2" value="75.4" spread="11.2"/>
                    <measurement group_id="O3" value="104" spread="10.7"/>
                    <measurement group_id="O4" value="144" spread="44.5"/>
                    <measurement group_id="O5" value="149" spread="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of LGX818 (Encorafenib)</title>
        <description>Tmax was defined as the time to reach maximum observed plasma concentration of encorafenib.</description>
        <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of LGX818 (Encorafenib)</title>
          <description>Tmax was defined as the time to reach maximum observed plasma concentration of encorafenib.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="17"/>
                <count group_id="O10" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.00" lower_limit="1.98" upper_limit="2.02"/>
                    <measurement group_id="O2" value="1.99" lower_limit="0.97" upper_limit="2.05"/>
                    <measurement group_id="O3" value="2.03" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O4" value="2.17" lower_limit="1.00" upper_limit="5.97"/>
                    <measurement group_id="O5" value="1.00" lower_limit="0.98" upper_limit="1.98"/>
                    <measurement group_id="O6" value="2.02" lower_limit="1.00" upper_limit="4.02"/>
                    <measurement group_id="O7" value="2.00" lower_limit="0.87" upper_limit="5.95"/>
                    <measurement group_id="O8" value="3.87" lower_limit="1.50" upper_limit="4.13"/>
                    <measurement group_id="O9" value="2.00" lower_limit="0.93" upper_limit="6.12"/>
                    <measurement group_id="O10" value="2.03" lower_limit="0.50" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of LGX818 (Encorafenib)</title>
        <description>Tmax, ss was defined as the time to reach maximum observed plasma concentration of LGX818 (encorafenib) at steady state.</description>
        <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of LGX818 (Encorafenib)</title>
          <description>Tmax, ss was defined as the time to reach maximum observed plasma concentration of LGX818 (encorafenib) at steady state.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="28"/>
                <count group_id="O10" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="0.98" lower_limit="0.75" upper_limit="4.00"/>
                    <measurement group_id="O6" value="1.98" lower_limit="1.00" upper_limit="3.98"/>
                    <measurement group_id="O7" value="2.00" lower_limit="1.12" upper_limit="4.02"/>
                    <measurement group_id="O8" value="3.92" lower_limit="0.50" upper_limit="4.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="7"/>
                    <count group_id="O7" value="8"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="11"/>
                    <count group_id="O10" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.51" lower_limit="1.00" upper_limit="2.02"/>
                    <measurement group_id="O2" value="2.00" lower_limit="1.00" upper_limit="4.03"/>
                    <measurement group_id="O3" value="1.98" lower_limit="0.97" upper_limit="4.00"/>
                    <measurement group_id="O4" value="1.98" lower_limit="1.05" upper_limit="2.05"/>
                    <measurement group_id="O5" value="2.00" lower_limit="1.00" upper_limit="2.02"/>
                    <measurement group_id="O6" value="2.02" lower_limit="1.05" upper_limit="6.00"/>
                    <measurement group_id="O7" value="3.00" lower_limit="1.92" upper_limit="7.98"/>
                    <measurement group_id="O8" value="2.27" lower_limit="2.07" upper_limit="3.97"/>
                    <measurement group_id="O9" value="1.15" lower_limit="0.98" upper_limit="5.93"/>
                    <measurement group_id="O10" value="2.00" lower_limit="1.88" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of BYL719 (Alpelisib)</title>
        <description>Tmax was defined as the time to reach maximum observed plasma concentration of alpelisib.</description>
        <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of BYL719 (Alpelisib)</title>
          <description>Tmax was defined as the time to reach maximum observed plasma concentration of alpelisib.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.98" lower_limit="0.98" upper_limit="2.00"/>
                    <measurement group_id="O2" value="3.97" lower_limit="1.93" upper_limit="6.00"/>
                    <measurement group_id="O3" value="2.00" lower_limit="0.87" upper_limit="5.95"/>
                    <measurement group_id="O4" value="2.10" lower_limit="1.50" upper_limit="4.50"/>
                    <measurement group_id="O5" value="2.05" lower_limit="1.92" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of BYL719 (Alpelisib)</title>
        <description>Tmax, ss was defined as the time to reach maximum observed plasma concentration of BYL719 (alpelisib) at steady state.</description>
        <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of BYL719 (Alpelisib)</title>
          <description>Tmax, ss was defined as the time to reach maximum observed plasma concentration of BYL719 (alpelisib) at steady state.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.97" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="3.99" lower_limit="1.00" upper_limit="7.97"/>
                    <measurement group_id="O3" value="2.15" lower_limit="1.12" upper_limit="4.02"/>
                    <measurement group_id="O4" value="4.07" lower_limit="0.00" upper_limit="4.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.02" lower_limit="1.00" upper_limit="4.00"/>
                    <measurement group_id="O2" value="4.00" lower_limit="1.05" upper_limit="6.00"/>
                    <measurement group_id="O3" value="3.93" lower_limit="2.00" upper_limit="5.98"/>
                    <measurement group_id="O4" value="4.03" lower_limit="3.97" upper_limit="8.00"/>
                    <measurement group_id="O5" value="2.02" lower_limit="1.00" upper_limit="6.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Last Observed Plasma Concentration (T-last) of LGX818 (Encorafenib)</title>
        <description>T-last was defined as the time to reach last observed plasma concentration of encorafenib.</description>
        <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Last Observed Plasma Concentration (T-last) of LGX818 (Encorafenib)</title>
          <description>T-last was defined as the time to reach last observed plasma concentration of encorafenib.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="9"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="17"/>
                <count group_id="O10" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.98" lower_limit="23.98" upper_limit="23.98"/>
                    <measurement group_id="O2" value="23.69" lower_limit="8.00" upper_limit="24.00"/>
                    <measurement group_id="O3" value="24.03" lower_limit="22.33" upper_limit="24.83"/>
                    <measurement group_id="O4" value="23.58" lower_limit="8.80" upper_limit="24.13"/>
                    <measurement group_id="O5" value="23.00" lower_limit="22.52" upper_limit="24.30"/>
                    <measurement group_id="O6" value="23.06" lower_limit="7.97" upper_limit="24.22"/>
                    <measurement group_id="O7" value="22.02" lower_limit="8.47" upper_limit="24.37"/>
                    <measurement group_id="O8" value="23.87" lower_limit="8.23" upper_limit="25.92"/>
                    <measurement group_id="O9" value="23.85" lower_limit="8.00" upper_limit="24.25"/>
                    <measurement group_id="O10" value="23.50" lower_limit="5.38" upper_limit="24.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of LGX818 (Encorafenib)</title>
        <description>T-last, ss was defined as the time to reach last observed plasma concentration of encorafenib at steady state.</description>
        <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of LGX818 (Encorafenib)</title>
          <description>T-last, ss was defined as the time to reach last observed plasma concentration of encorafenib at steady state.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="28"/>
                <count group_id="O10" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="0"/>
                    <count group_id="O10" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O5" value="23.78" lower_limit="23.75" upper_limit="23.92"/>
                    <measurement group_id="O6" value="23.36" lower_limit="7.58" upper_limit="23.98"/>
                    <measurement group_id="O7" value="23.92" lower_limit="23.48" upper_limit="23.97"/>
                    <measurement group_id="O8" value="23.87" lower_limit="21.83" upper_limit="23.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="5"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="7"/>
                    <count group_id="O7" value="8"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="11"/>
                    <count group_id="O10" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.89" lower_limit="23.88" upper_limit="23.90"/>
                    <measurement group_id="O2" value="22.13" lower_limit="7.30" upper_limit="23.85"/>
                    <measurement group_id="O3" value="14.05" lower_limit="6.00" upper_limit="24.67"/>
                    <measurement group_id="O4" value="23.45" lower_limit="6.00" upper_limit="23.98"/>
                    <measurement group_id="O5" value="23.97" lower_limit="7.25" upper_limit="24.20"/>
                    <measurement group_id="O6" value="23.08" lower_limit="8.00" upper_limit="23.98"/>
                    <measurement group_id="O7" value="23.94" lower_limit="7.00" upper_limit="24.38"/>
                    <measurement group_id="O8" value="23.42" lower_limit="22.08" upper_limit="23.58"/>
                    <measurement group_id="O9" value="23.80" lower_limit="8.07" upper_limit="24.17"/>
                    <measurement group_id="O10" value="23.42" lower_limit="8.00" upper_limit="24.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Last Observed Plasma Concentration (T-last) of BYL719 (Alpelisib)</title>
        <description>T-last was defined as the time to reach last observed plasma concentration of alpelisib.</description>
        <time_frame>Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Last Observed Plasma Concentration (T-last) of BYL719 (Alpelisib)</title>
          <description>T-last was defined as the time to reach last observed plasma concentration of alpelisib.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.00" lower_limit="22.52" upper_limit="24.30"/>
                    <measurement group_id="O2" value="23.06" lower_limit="7.97" upper_limit="24.22"/>
                    <measurement group_id="O3" value="22.76" lower_limit="8.47" upper_limit="24.37"/>
                    <measurement group_id="O4" value="23.87" lower_limit="8.23" upper_limit="25.92"/>
                    <measurement group_id="O5" value="23.17" lower_limit="7.92" upper_limit="24.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of BYL719 (Alpelisib)</title>
        <description>T-last, ss was defined as the time to reach last observed plasma concentration of alpelisib at steady state.</description>
        <time_frame>Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of BYL719 (Alpelisib)</title>
          <description>T-last, ss was defined as the time to reach last observed plasma concentration of alpelisib at steady state.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.78" lower_limit="23.75" upper_limit="23.92"/>
                    <measurement group_id="O2" value="23.36" lower_limit="7.58" upper_limit="23.98"/>
                    <measurement group_id="O3" value="23.87" lower_limit="7.75" upper_limit="23.97"/>
                    <measurement group_id="O4" value="23.87" lower_limit="21.83" upper_limit="23.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="3"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.97" lower_limit="7.25" upper_limit="24.20"/>
                    <measurement group_id="O2" value="23.08" lower_limit="8.00" upper_limit="23.98"/>
                    <measurement group_id="O3" value="23.94" lower_limit="7.00" upper_limit="24.38"/>
                    <measurement group_id="O4" value="23.47" lower_limit="22.08" upper_limit="23.58"/>
                    <measurement group_id="O5" value="23.77" lower_limit="7.00" upper_limit="25.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Trough Concentration at Steady State (Ctrough, ss) of LGX818 (Encorafenib)</title>
        <description>Ctrough, ss was defined as plasma trough concentration of encorafenib at steady state.</description>
        <time_frame>Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Trough Concentration at Steady State (Ctrough, ss) of LGX818 (Encorafenib)</title>
          <description>Ctrough, ss was defined as plasma trough concentration of encorafenib at steady state.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="7"/>
                <count group_id="O7" value="8"/>
                <count group_id="O8" value="1"/>
                <count group_id="O9" value="11"/>
                <count group_id="O10" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.87" spread="6.69"/>
                    <measurement group_id="O2" value="20.5" spread="28.0"/>
                    <measurement group_id="O3" value="15.7" spread="22.0"/>
                    <measurement group_id="O4" value="20.6" spread="18.4"/>
                    <measurement group_id="O5" value="7.69" spread="1.76"/>
                    <measurement group_id="O6" value="10.4" spread="5.05"/>
                    <measurement group_id="O7" value="26.5" spread="31.4"/>
                    <measurement group_id="O8" value="29.2" spread="NA">Standard deviation was not estimated as only 1 participant was analyzed.</measurement>
                    <measurement group_id="O9" value="9.24" spread="5.19"/>
                    <measurement group_id="O10" value="15.0" spread="17.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Trough Concentration at Steady State (Ctrough, ss) of BYL719 (Alpelisib)</title>
        <description>Ctrough, ss was defined as plasma trough concentration of alpelisib at steady state.</description>
        <time_frame>Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose</time_frame>
        <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Trough Concentration at Steady State (Ctrough, ss) of BYL719 (Alpelisib)</title>
          <description>Ctrough, ss was defined as plasma trough concentration of alpelisib at steady state.</description>
          <population>The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>nanogram per milliliter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="1"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.7" spread="21.0"/>
                    <measurement group_id="O2" value="108" spread="41.1"/>
                    <measurement group_id="O3" value="283" spread="156"/>
                    <measurement group_id="O4" value="66.0" spread="NA">Standard deviation was not estimable as only 1 participant was analyzed.</measurement>
                    <measurement group_id="O5" value="141" spread="76.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as the time (in months) from the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.</description>
        <time_frame>From the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first (up to 43 months)</time_frame>
        <population>The FAS1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as the time (in months) from the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.</description>
          <population>The FAS1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="50"/>
                <count group_id="O10" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.0" lower_limit="14.8" upper_limit="15.2"/>
                    <measurement group_id="O2" value="5.4" lower_limit="1.2" upper_limit="7.8"/>
                    <measurement group_id="O3" value="NA" lower_limit="2.9" upper_limit="NA">Median and upper limit of 95% Confidence Interval (CI) were not estimable due to fewer participants with event.</measurement>
                    <measurement group_id="O4" value="16.6" lower_limit="3.9" upper_limit="23.5"/>
                    <measurement group_id="O5" value="6.6" lower_limit="5.0" upper_limit="NA">Upper limit of 95% CI was not reached at the time of data cut-off.</measurement>
                    <measurement group_id="O6" value="8.7" lower_limit="3.8" upper_limit="27.1"/>
                    <measurement group_id="O7" value="9.8" lower_limit="3.7" upper_limit="25.2"/>
                    <measurement group_id="O8" value="NA" lower_limit="5.3" upper_limit="NA">Median and upper limit of 95% Confidence Interval (CI) were not estimable due to fewer participants with event.</measurement>
                    <measurement group_id="O9" value="9.3" lower_limit="5.8" upper_limit="15.6"/>
                    <measurement group_id="O10" value="8.5" lower_limit="6.1" upper_limit="15.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR)</title>
        <description>Overall response rate as assessed by the investigator per RECIST v1.1, was defined as percentage of participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-nodal target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Only confirmed CR and PR are counted (those confirmed at least 4 weeks).</description>
        <time_frame>From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause (maximum up to 43 months)</time_frame>
        <population>The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR)</title>
          <description>Overall response rate as assessed by the investigator per RECIST v1.1, was defined as percentage of participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-nodal target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (&lt;) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Only confirmed CR and PR are counted (those confirmed at least 4 weeks).</description>
          <population>The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="7"/>
                <count group_id="O9" value="50"/>
                <count group_id="O10" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="1.3" upper_limit="98.7"/>
                    <measurement group_id="O2" value="14.3" lower_limit="0.4" upper_limit="57.9"/>
                    <measurement group_id="O3" value="11.1" lower_limit="0.3" upper_limit="48.2"/>
                    <measurement group_id="O4" value="25.0" lower_limit="3.2" upper_limit="65.1"/>
                    <measurement group_id="O5" value="33.3" lower_limit="0.8" upper_limit="90.6"/>
                    <measurement group_id="O6" value="25.0" lower_limit="3.2" upper_limit="65.1"/>
                    <measurement group_id="O7" value="20.0" lower_limit="2.5" upper_limit="55.6"/>
                    <measurement group_id="O8" value="0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O9" value="24.0" lower_limit="13.1" upper_limit="38.2"/>
                    <measurement group_id="O10" value="26.9" lower_limit="15.6" upper_limit="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR: Time between date of the first documented response (CR or PR) and the date of first documented PD or death due to underlying cancer. If PD or death due to underlying cancer not occurred, then participant was censored at the date of last tumor assessment other than unknown. DOR was calculated for responders (confirmed) only. CR: Disappearance of all target, non-target lesions sustained for &gt;=4 weeks and any pathological lymph nodes reduced in short axis to &lt;10mm. PR: &gt;=30% decrease in sum of diameters of target lesions, taking as reference baseline sum of diameter. PD for target lesions: At least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment, with absolute increase of &gt;=5 mm, or appearance of &gt;=1 new lesions. PD for non-target lesions: Unequivocal progression of pre-existing lesions/increase in overall tumor burden leading to discontinuation of therapy or appearance of new unequivocal malignant lesion.</description>
        <time_frame>From the first documentation of OR (confirmed CR or PR) to first documentation of PD/death due to any cause or censoring date, whichever occurred first (up to 43 months)</time_frame>
        <population>The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>DOR: Time between date of the first documented response (CR or PR) and the date of first documented PD or death due to underlying cancer. If PD or death due to underlying cancer not occurred, then participant was censored at the date of last tumor assessment other than unknown. DOR was calculated for responders (confirmed) only. CR: Disappearance of all target, non-target lesions sustained for &gt;=4 weeks and any pathological lymph nodes reduced in short axis to &lt;10mm. PR: &gt;=30% decrease in sum of diameters of target lesions, taking as reference baseline sum of diameter. PD for target lesions: At least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment, with absolute increase of &gt;=5 mm, or appearance of &gt;=1 new lesions. PD for non-target lesions: Unequivocal progression of pre-existing lesions/increase in overall tumor burden leading to discontinuation of therapy or appearance of new unequivocal malignant lesion.</description>
          <population>The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="11"/>
                <count group_id="O10" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="NA" upper_limit="NA">CI values were not estimated due to single participant.</measurement>
                    <measurement group_id="O2" value="2.3" lower_limit="NA" upper_limit="NA">CI values were not estimated due to single participant.</measurement>
                    <measurement group_id="O3" value="21.7" lower_limit="NA" upper_limit="NA">CI values were not estimated due to single participant.</measurement>
                    <measurement group_id="O4" value="8.1" lower_limit="5.4" upper_limit="10.9"/>
                    <measurement group_id="O5" value="3.9" lower_limit="NA" upper_limit="NA">CI values were not estimated due to single participant.</measurement>
                    <measurement group_id="O6" value="3.6" lower_limit="2.8" upper_limit="4.4"/>
                    <measurement group_id="O7" value="3.3" lower_limit="2.8" upper_limit="3.8"/>
                    <measurement group_id="O9" value="5.6" lower_limit="2.0" upper_limit="NA">Upper limit of 95% CI was not estimable due to low numbers of participant with events.</measurement>
                    <measurement group_id="O10" value="5.3" lower_limit="2.7" upper_limit="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Response (TTR)</title>
        <description>TTR as assessed by investigator according to RECIST v1.1, was defined as the time (in months) from date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to &lt;10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival.</description>
        <time_frame>From the date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first (maximum up to 43 months)</time_frame>
        <population>The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O9">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O10">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Response (TTR)</title>
          <description>TTR as assessed by investigator according to RECIST v1.1, was defined as the time (in months) from date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to &lt;10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival.</description>
          <population>The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="1"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="1"/>
                <count group_id="O6" value="2"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="0"/>
                <count group_id="O9" value="12"/>
                <count group_id="O10" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="NA" upper_limit="NA">CI values were not estimated due to single participant.</measurement>
                    <measurement group_id="O2" value="1.4" lower_limit="NA" upper_limit="NA">CI values were not estimated due to single participant.</measurement>
                    <measurement group_id="O3" value="3.9" lower_limit="NA" upper_limit="NA">CI values were not estimated due to single participant.</measurement>
                    <measurement group_id="O4" value="4.0" lower_limit="1.4" upper_limit="6.7"/>
                    <measurement group_id="O5" value="1.5" lower_limit="NA" upper_limit="NA">CI values were not estimated due to single participant.</measurement>
                    <measurement group_id="O6" value="3.5" lower_limit="1.4" upper_limit="5.6"/>
                    <measurement group_id="O7" value="2.0" lower_limit="1.4" upper_limit="2.5"/>
                    <measurement group_id="O9" value="1.7" lower_limit="1.2" upper_limit="7.7"/>
                    <measurement group_id="O10" value="1.5" lower_limit="1.4" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b: Progression Free Survival (PFS)</title>
        <description>PFS was defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. Participants who did not progress per RECIST v1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.</description>
        <time_frame>From date of start of treatment to the date of event defined as the first documented progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)</time_frame>
        <population>The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
            <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
            <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O4">
            <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
            <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O5">
            <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O6">
            <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O7">
            <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O8">
            <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
            <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b: Progression Free Survival (PFS)</title>
          <description>PFS was defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. Participants who did not progress per RECIST v1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.</description>
          <population>The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="3"/>
                <count group_id="O6" value="8"/>
                <count group_id="O7" value="10"/>
                <count group_id="O8" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.0" lower_limit="10.6" upper_limit="13.4"/>
                    <measurement group_id="O2" value="3.7" lower_limit="1.2" upper_limit="4.1"/>
                    <measurement group_id="O3" value="2.8" lower_limit="1.3" upper_limit="4.3"/>
                    <measurement group_id="O4" value="12.0" lower_limit="1.8" upper_limit="12.3"/>
                    <measurement group_id="O5" value="5.4" lower_limit="4.4" upper_limit="9.1"/>
                    <measurement group_id="O6" value="4.3" lower_limit="3.8" upper_limit="13.6"/>
                    <measurement group_id="O7" value="4.1" lower_limit="1.7" upper_limit="5.8"/>
                    <measurement group_id="O8" value="4.2" lower_limit="2.9" upper_limit="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Number of Participants With Any Variant in Gene Status at Baseline</title>
        <description>Gene alterations/expression relevant to the RAF/MEK/ERK (proto-oncogene serine/threonine-protein kinase/ mitogen-activated ERK kinase/ extracellular signal-regulated kinases) and EGFR/PI3K/AKT (epidermal growth factor receptor/ phosphatidylinositol 3-kinase/ protein kinase B) pathways in tumor tissue, baseline molecular status (mutation/amplification/expression) in tumor tissue of potential predictive markers of tumor response or resistance i.e. BRAF (v-raf murine sarcoma viral oncogene homolog B1), HRAS (harvey rat sarcoma protein), KRAS (V-Ki-ras2 kirsten rat sarcoma viral oncogene homolog B1), NRAS (neuroblastoma RAS viral oncogene homolog), PTEN (phosphatase and tensin homolog), PIK3CA (phosphatidylinositol 3-kinase gene), MAP2K1 (mitogen-activated protein kinase 1), MAP2K2 (mitogen-activated protein kinase 2), ARAF, c-MET, RAF1, EGFR was analyzed.</description>
        <time_frame>Baseline (Day 1)</time_frame>
        <population>The FAS2 comprised all randomized participants in Phase 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: LGX818 200 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
            <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Number of Participants With Any Variant in Gene Status at Baseline</title>
          <description>Gene alterations/expression relevant to the RAF/MEK/ERK (proto-oncogene serine/threonine-protein kinase/ mitogen-activated ERK kinase/ extracellular signal-regulated kinases) and EGFR/PI3K/AKT (epidermal growth factor receptor/ phosphatidylinositol 3-kinase/ protein kinase B) pathways in tumor tissue, baseline molecular status (mutation/amplification/expression) in tumor tissue of potential predictive markers of tumor response or resistance i.e. BRAF (v-raf murine sarcoma viral oncogene homolog B1), HRAS (harvey rat sarcoma protein), KRAS (V-Ki-ras2 kirsten rat sarcoma viral oncogene homolog B1), NRAS (neuroblastoma RAS viral oncogene homolog), PTEN (phosphatase and tensin homolog), PIK3CA (phosphatidylinositol 3-kinase gene), MAP2K1 (mitogen-activated protein kinase 1), MAP2K2 (mitogen-activated protein kinase 2), ARAF, c-MET, RAF1, EGFR was analyzed.</description>
          <population>The FAS2 comprised all randomized participants in Phase 2.</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="50"/>
                <count group_id="O2" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)</time_frame>
      <desc>Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Phase 1b: LGX818 100 mg + Cetuximab</title>
          <description>Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E2">
          <title>Phase 1b: LGX818 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E3">
          <title>Phase 1b: LGX818 400 mg + Cetuximab</title>
          <description>Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E4">
          <title>Phase 1b: LGX818 450 mg + Cetuximab</title>
          <description>Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E5">
          <title>Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E6">
          <title>Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E7">
          <title>Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E8">
          <title>Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab</title>
          <description>Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E9">
          <title>Phase 2: LGX818 200 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
        <group group_id="E10">
          <title>Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab</title>
          <description>Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v19.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="25" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="33" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Chorioretinopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrointestinal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Duodenal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrointestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Large intestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Jaundice cholestatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Clostridial infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Incision site abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Refractoriness to platelet transfusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Brain natriuretic peptide increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </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="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Malignant melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eye naevus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Thrombosis in device</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Female genital tract fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dyspnoea at rest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pelvic venous thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v19.0</default_vocab>
        <default_assessment>Non-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="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="10" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="7" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="50" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="52" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="12" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Aortic valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diastolic dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tachyarrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Atrial tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Distichiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ear congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Middle ear inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blepharitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abnormal sensation in eye</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Chalazion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Trichomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Accommodation disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Retinopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blindness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eczema eyelids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Erythema of eyelid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eyelid irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Periorbital oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Retinal degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vitreous floaters</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="25" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="23" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="30" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="21" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="29" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="18" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haemorrhoidal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Painful defaecation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal adhesions</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anal incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Frequent bowel movements</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lip oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lip pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lower gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oesophageal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Peritoneal adhesions</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rectal tenesmus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abdominal rigidity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anal fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Enterovesical fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Faeces discoloured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Large intestinal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lip blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Mouth haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral mucosal blistering</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="6" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="25" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="27" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Adverse event</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Mucosal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Early satiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hepatobiliary disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hepatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Jaundice</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hepatic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haemophilus bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Biliary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Angular cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Body tinea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin candida</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anal abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gastric infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Incision site abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lip infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nail infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Inflammation of wound</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Stoma site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vascular access complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="5" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="19" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood iron decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Amylase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood albumin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ejection fraction decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Troponin T increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood creatine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood iron decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood phosphorus decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eastern Cooperative Oncology Group performance status improved</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Electrocardiogram T wave inversion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Macular reflex abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="16" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="19" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="10" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="18" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Food craving</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperlipasaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="12" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="10" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="12" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="19" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="15" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dysplastic naevus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Endometrial neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Melanocytic naevus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="6" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pyogenic granuloma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tumour associated fever</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Fibroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Acrochordon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Keratoacanthoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Malignant ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Neoplasm skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oral fibroma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Seborrhoeic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eye naevus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="17" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="13" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Memory impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ageusia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Horner's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Akathisia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dysaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Fine motor skill dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Thrombosis in device</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="8" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Fear</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </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="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Micturition urgency</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cystitis noninfective</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Polyuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Renal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Strangury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urethral pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary incontinence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematospermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nipple pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vaginal discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vaginal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dyspareunia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Prostatism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="8" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="7" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dyspnoea at rest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nasal crusting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Orthopnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Choking sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Sputum discoloured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Tachypnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Increased viscosity of bronchial secretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="18" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="15" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="9" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="12" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="11" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pain of skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="7" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="9" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin hyperpigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Onychomadesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin fissures</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="5" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nail ridging</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash morbilliform</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Toxic skin eruption</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="6" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="4" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Cutaneous symptom</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hair disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hirsutism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypertrichosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Lipohypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Miliaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Precancerous skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Solar dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Decubitus ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Erythema multiforme</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Melanosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Onychoclasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Onycholysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin depigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Skin hypopigmentation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Splinter haemorrhages</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="4" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Bloody discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pallor</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Venous thrombosis limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="52"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT01719380
org study id: CLGX818X2103
secondary id: C4221002
secondary id: 2012-002138-35
nct id: NCT01719380
lead sponsor: 
This study will assess the safety and efficacy of LGX818 when combined with cetuximab or
      combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1
time frame: Cycle 1: Day 1 to Day 28
description: DLTs were defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment and meets any of the criteria included blood and lymphatic system disorders, investigations (blood, renal, hepatic, metabolic), skin and subcutaneous tissue disorders: rash, HFSR (hand foot skin reaction) and/or photosensitivity, metabolism and nutrition disorders: hyperglycemia, gastrointestinal disorders, cardiac disorders, vascular disorders, general disorders and administration site conditions, tumor lysis syndrome, ophthalmologic and other adverse events: study drug-related fever, alkaline phosphatase elevation.
measure: Phase 2: Progression Free Survival (PFS)
time frame: From the date of randomization until the first documentation of disease progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)
description: PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. Participants who did not progress per RECIST (Response Evaluation Criteria in Solid Tumors) version (v) 1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.
measure: Number of Participants With Treatment - Emergent Adverse Events of Grade 3 or 4 Severity Based on National Cancer Institute of Common Terminology Criteria (NCI-CTCAE), Version 4.0
time frame: From screening up to 30 days after the last dose of study treatment (for a maximum duration of 43 months, approximately)
description: An AE was any untoward medical occurrence attributed to study drug in participants who received study drug. As per NCI-CTCAE v4.0, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to study drug. Treatment-emergent AEs are between first dose of study drug and up to 30 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. Number of participants with any Grade 3 or 4 treatment-emergent AE were reported in this outcome measure.
measure: Apparent Total Plasma Clearance (CL/F) of LGX818 (Encorafenib)
time frame: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure: Apparent Total Plasma Clearance at Steady State (CL/F, ss) of LGX818 (Encorafenib)
time frame: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure: Apparent Total Plasma Clearance (CL/F) of BYL719 (Alpelisib)
time frame: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure: Apparent Total Plasma Clearance at Steady State (CL/F, ss) of BYL719 (Alpelisib)
time frame: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
measure: Apparent Terminal Volume of Distribution (Vz/F) of LGX818 (Encorafenib)
time frame: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
measure: Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of LGX818 (Encorafenib)
time frame: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Volume of distribution at steady state is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.
measure: Apparent Terminal Volume of Distribution (Vz/F) of BYL719 (Alpelisib)
time frame: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
measure: Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of BYL719 (Alpelisib)
time frame: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of LGX818 (Encorafenib)
time frame: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Tmax was defined as the time to reach maximum observed plasma concentration of encorafenib.
measure: Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of LGX818 (Encorafenib)
time frame: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Tmax, ss was defined as the time to reach maximum observed plasma concentration of LGX818 (encorafenib) at steady state.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of BYL719 (Alpelisib)
time frame: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Tmax was defined as the time to reach maximum observed plasma concentration of alpelisib.
measure: Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of BYL719 (Alpelisib)
time frame: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Tmax, ss was defined as the time to reach maximum observed plasma concentration of BYL719 (alpelisib) at steady state.
measure: Time of Last Observed Plasma Concentration (T-last) of LGX818 (Encorafenib)
time frame: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: T-last was defined as the time to reach last observed plasma concentration of encorafenib.
measure: Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of LGX818 (Encorafenib)
time frame: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: T-last, ss was defined as the time to reach last observed plasma concentration of encorafenib at steady state.
measure: Time of Last Observed Plasma Concentration (T-last) of BYL719 (Alpelisib)
time frame: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: T-last was defined as the time to reach last observed plasma concentration of alpelisib.
measure: Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of BYL719 (Alpelisib)
time frame: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: T-last, ss was defined as the time to reach last observed plasma concentration of alpelisib at steady state.
measure: Plasma Trough Concentration at Steady State (Ctrough, ss) of LGX818 (Encorafenib)
time frame: Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Ctrough, ss was defined as plasma trough concentration of encorafenib at steady state.
measure: Plasma Trough Concentration at Steady State (Ctrough, ss) of BYL719 (Alpelisib)
time frame: Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dose
description: Ctrough, ss was defined as plasma trough concentration of alpelisib at steady state.
measure: Overall Survival (OS)
time frame: From the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first (up to 43 months)
description: OS was defined as the time (in months) from the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
measure: Overall Response Rate (ORR)
time frame: From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause (maximum up to 43 months)
description: Overall response rate as assessed by the investigator per RECIST v1.1, was defined as percentage of participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-nodal target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Only confirmed CR and PR are counted (those confirmed at least 4 weeks).
measure: Duration of Response (DOR)
time frame: From the first documentation of OR (confirmed CR or PR) to first documentation of PD/death due to any cause or censoring date, whichever occurred first (up to 43 months)
description: DOR: Time between date of the first documented response (CR or PR) and the date of first documented PD or death due to underlying cancer. If PD or death due to underlying cancer not occurred, then participant was censored at the date of last tumor assessment other than unknown. DOR was calculated for responders (confirmed) only. CR: Disappearance of all target, non-target lesions sustained for >=4 weeks and any pathological lymph nodes reduced in short axis to <10mm. PR: >=30% decrease in sum of diameters of target lesions, taking as reference baseline sum of diameter. PD for target lesions: At least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment, with absolute increase of >=5 mm, or appearance of >=1 new lesions. PD for non-target lesions: Unequivocal progression of pre-existing lesions/increase in overall tumor burden leading to discontinuation of therapy or appearance of new unequivocal malignant lesion.
measure: Time to Response (TTR)
time frame: From the date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first (maximum up to 43 months)
description: TTR as assessed by investigator according to RECIST v1.1, was defined as the time (in months) from date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to <10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival.
measure: Phase 1b: Progression Free Survival (PFS)
time frame: From date of start of treatment to the date of event defined as the first documented progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)
description: PFS was defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. Participants who did not progress per RECIST v1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.
measure: Phase 2: Number of Participants With Any Variant in Gene Status at Baseline
time frame: Baseline (Day 1)
description: Gene alterations/expression relevant to the RAF/MEK/ERK (proto-oncogene serine/threonine-protein kinase/ mitogen-activated ERK kinase/ extracellular signal-regulated kinases) and EGFR/PI3K/AKT (epidermal growth factor receptor/ phosphatidylinositol 3-kinase/ protein kinase B) pathways in tumor tissue, baseline molecular status (mutation/amplification/expression) in tumor tissue of potential predictive markers of tumor response or resistance i.e. BRAF (v-raf murine sarcoma viral oncogene homolog B1), HRAS (harvey rat sarcoma protein), KRAS (V-Ki-ras2 kirsten rat sarcoma viral oncogene homolog B1), NRAS (neuroblastoma RAS viral oncogene homolog), PTEN (phosphatase and tensin homolog), PIK3CA (phosphatidylinositol 3-kinase gene), MAP2K1 (mitogen-activated protein kinase 1), MAP2K2 (mitogen-activated protein kinase 2), ARAF, c-MET, RAF1, EGFR was analyzed.
arm group label: LGX818 + cetuximab
arm group type: Experimental
arm group label: LGX818 + BYL719 + cetuximab
arm group type: Experimental
intervention type: Drug
intervention name: LGX818
arm group label: LGX818 + BYL719 + cetuximab
arm group label: LGX818 + cetuximab
intervention type: Drug
intervention name: Cetuximab
arm group label: LGX818 + BYL719 + cetuximab
arm group label: LGX818 + cetuximab
intervention type: Drug
intervention name: BYL719
arm group label: LGX818 + BYL719 + cetuximab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Australia
country: Belgium
country: Canada
country: France
country: Germany
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Norway
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Cetuximab
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
participant flow: 
baseline: 
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reported events: 
certain agreements: 
point of contact: 