<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/NCT03031782</url>
  </required_header>
  <id_info>
    <org_study_id>CAIN457F2304</org_study_id>
    <secondary_id>2016-003761-26</secondary_id>
    <nct_id>NCT03031782</nct_id>
  </id_info>
  <brief_title>Secukinumab Safety and Efficacy in Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related Arthritis (ERA)</brief_title>
  <official_title>A Three-part Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Secukinumab Treatment in Juvenile Idiopathic Arthritis Subtypes of Psoriatic and Enthesitis-related Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to&#xD;
      investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic&#xD;
      Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related&#xD;
      Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period)&#xD;
      consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a&#xD;
      randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment&#xD;
      Period 2&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TP1: All eligible subjects entered TP1 to receive 12-weeks of open-label secukinumab at a&#xD;
      dose predicted to achieve secukinumab serum levels equivalent to adults administered a 150 mg&#xD;
      dose regimen. Secukinumab was administered s.c. weekly for the first 4 weeks (Baseline, Weeks&#xD;
      1, 2, 3, 4) and then every 4 weeks thereafter. Clinical response (JIA ACR 30) was assessed at&#xD;
      Week 12. Responders advanced to TP2 and non-responders exited the trial (early termination&#xD;
      visit and entered into the Post-treatment follow-up period).&#xD;
&#xD;
      TP2: Subjects who were a responder (JIA ACR 30) at Week 12 entered the double-blind&#xD;
      withdrawal TP2 and were randomized 1:1 to either secukinumab or placebo on that visit and&#xD;
      then every 4 weeks, until either experiencing a disease flare or completion of TP2. TP2 was&#xD;
      event driven and was planned to be closed when 33 subjects experienced a disease flare as per&#xD;
      JIA definition. Alternatively, the study could be closed when all subjects reached the total&#xD;
      study duration of 104 Weeks and therefore subjects who did not experience a disease flare&#xD;
      remained in TP2 for the duration of the study and completed the study without entering into&#xD;
      TP3&#xD;
&#xD;
      TP3: Subjects experiencing a disease flare in TP2 immediately entered TP3 to receive&#xD;
      openlabel secukinumab every 4 weeks until total study duration of 104 weeks for that subject&#xD;
      was achieved.&#xD;
&#xD;
      Post-treatment follow-up: The post-treatment follow-up period (lasting 12 weeks from the last&#xD;
      study drug administration) was required for all subjects, unless they qualified and entered&#xD;
      the secukinumab extension trial. All subjects were expected to participate in the&#xD;
      post-treatment follow up period, except for those entering the extension study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2017</start_date>
  <completion_date type="Actual">November 9, 2020</completion_date>
  <primary_completion_date type="Actual">October 7, 2020</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Experiencing a Flare During Treatment Period 2</measure>
    <time_frame>From Week 12 until max Week 104</time_frame>
    <description>Survival analysis of time to flare in treatment period 2 (TP2) FAS2&#xD;
Subjects are either ERA or JPsA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category</measure>
    <time_frame>baseline, week 12</time_frame>
    <description>Summary of JIA ACR 30/50/70/90/100 for all subjects and each JIA category - TP1 (FAS1)&#xD;
The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components&#xD;
Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.&#xD;
Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.&#xD;
Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)&#xD;
Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)&#xD;
Number of joints with limitation of motion&#xD;
Laboratory measure of inflammation: CRP (mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total</measure>
    <time_frame>baseline, week 12</time_frame>
    <description>Summary of JIA ACR 30/50/70/90/100 for all subjects - TP1 (FAS1)&#xD;
The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components&#xD;
Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.&#xD;
Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.&#xD;
Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)&#xD;
Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)&#xD;
Number of joints with limitation of motion&#xD;
Laboratory measure of inflammation: CRP (mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline for JIA ACR Core Components in TP1</measure>
    <time_frame>baseline, week 12</time_frame>
    <description>Summary of JIA ACR core components for all subjects and each JIA category - Treatment period 1&#xD;
Negative percent change indicates improvement&#xD;
Physician global assessment of disease activity (VAS mm) 0 (no disease activity) - 100 (very severe); Parent or subject global assessment of overall well-being (VAS mm) 0 (very well) - 100 (very poor); CHAQ (Childhood Health Assessment Questionnaire) 0 - 3 (most severe); Number of joints with active arthritis 0 - 73; Number of joints with limited range of motion 0 - 69.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change in C-reactive Protein Standardized Value (mg/L)</measure>
    <time_frame>baseline, week 12</time_frame>
    <description>Median Percent Change from baseline for C-reactive protein standardized value (mg/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score</measure>
    <time_frame>12 weeks</time_frame>
    <description>JADAS change from baseline for all subjects in Treatment period 1. JADAS-27 (Juvenile Arthritis Disease Activity Score in 27 joints) ranges from 0 to 57 and JADAS-71 ranges from 0 to 101 (higher scores indicate more disease activity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Enthesitis Events - TP1 (FAS1)</measure>
    <time_frame>Baseline and week 12</time_frame>
    <description>Enthesitis swollen joint count range is 0-16. Zero is worst, and 16 is best&#xD;
A total of 16 entheseal sites were assessed for the presence or absence of tenderness of enthesitis.&#xD;
This is the mean (SD) enthesitis count (range 0-16) for FAS subjects&#xD;
A zero score means no enthesitis, so a zero score is better for the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Dactylitis Count</measure>
    <time_frame>baseline, week 12</time_frame>
    <description>Summary of total dactylitis count for all subjects - TP1 (FAS1)&#xD;
Total dactylitis count ranges from 0 to 20. A zero score means no dactylitis, so a zero score is better for the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti-secukinumab Anitbodies</measure>
    <time_frame>104 weeks</time_frame>
    <description>Blood samples for immunogenicity (anti-AIN457 antibodies) were taken pre-dose at the scheduled time points. In addition, if a subject discontinued from the study at any time, he/she provided a sample at the last visit. All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. An Electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secukinumab Serum Concentration</measure>
    <time_frame>baseline, week 12</time_frame>
    <description>Summary of pharmacokinetic concentrations - Treatment period 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Inactive Disease Status for All Subjects - TP1 (FAS1)</measure>
    <time_frame>week 12</time_frame>
    <description>Summary of inactive disease status for all subjects - TP1 (FAS1)&#xD;
Clinical inactive disease definition was adapted from the JIA ACR criteria.&#xD;
All were required to be met:&#xD;
No joints with active arthritis&#xD;
No uveitis&#xD;
CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA&#xD;
Physician's global assessment of disease activity score ≤ 10mm&#xD;
Duration of morning stiffness attributable to JIA ≤15 min</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Juvenile Psoriatic Arthritis</condition>
  <condition>Enthesitis-related Arthritis</condition>
  <arm_group>
    <arm_group_label>Treatment Period 2 - active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Period 2 - placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo comparator (matched to secukinumab treatment) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>secukinumab</intervention_name>
    <description>secukinumab is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.</description>
    <arm_group_label>Treatment Period 2 - active</arm_group_label>
    <other_name>AIN457</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Matched placebo to AIN457 for use in the double blind Treatment Period 2</description>
    <arm_group_label>Treatment Period 2 - placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic&#xD;
             arthritis (JPsA) according to the International League of Associations for&#xD;
             Rheumatology (ILAR) classification criteria of at least 6 months duration.&#xD;
&#xD;
          2. Active disease (ERA or JPsA) defined as having both:&#xD;
&#xD;
               -  at least 3 active joints&#xD;
&#xD;
               -  at least 1 site of active enthesitis at baseline or documented by history.&#xD;
&#xD;
          3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal&#xD;
             anti-inflammatory drugs(NSAID)&#xD;
&#xD;
          4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying&#xD;
             antirheumatic drugs (DMARD)&#xD;
&#xD;
          5. No concomitant use of second line agents such as disease-modifying and/or&#xD;
             immunosuppressive drugs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA.&#xD;
&#xD;
          2. Patients who have ever received biologic immunomodulating agents&#xD;
&#xD;
          3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA&#xD;
             patients only).&#xD;
&#xD;
          4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled&#xD;
             uveitis.&#xD;
&#xD;
        Other protocol-defined inclusion/exclusion criteria apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Laeken</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Augustin</city>
        <zip>53757</zip>
        <country>Germany</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Genova</city>
        <state>GE</state>
        <zip>16147</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Krakow</city>
        <zip>31503</zip>
        <country>Poland</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620149</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
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        <zip>194100</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Voronezh</city>
        <zip>394036</zip>
        <country>Russian Federation</country>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7925</zip>
        <country>South Africa</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Panorama</city>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
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  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>Galicia</state>
        <zip>15706</zip>
        <country>Spain</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <state>Halkali</state>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <state>TUR</state>
        <zip>34098</zip>
        <country>Turkey</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
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    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34766</zip>
        <country>Turkey</country>
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      <name>Novartis Investigative Site</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8BJ</zip>
        <country>United Kingdom</country>
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  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Liverpool</city>
        <zip>L12 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 2, 2016</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>May 6, 2021</results_first_submitted>
  <results_first_submitted_qc>August 12, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 15, 2022</results_first_posted>
  <disposition_first_submitted>May 19, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 12, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 15, 2022</disposition_first_posted>
  <last_update_submitted>August 12, 2022</last_update_submitted>
  <last_update_submitted_qc>August 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JIA</keyword>
  <keyword>JPsA</keyword>
  <keyword>ERA</keyword>
  <keyword>Secukinumab</keyword>
  <keyword>ILAR</keyword>
  <keyword>Arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Enthesopathy</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03031782/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03031782/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>86 subjects entered TP1</recruitment_details>
      <pre_assignment_details>AIN457 treatment group refers to all subjects who did not take any placebo before or during the period in the study. The term Placebo in TP2 refers to all subjects who took placebo in TP2 and secukinumab in other periods. For ease of reading, Placebo in TP2 treatment group is referred as placebo treatment group or placebo hereafter in this document.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>AIN457 in TP1</title>
          <description>Treatment Period 1</description>
        </group>
        <group group_id="P2">
          <title>AIN457 in TP 2</title>
          <description>Treatment Period 2</description>
        </group>
        <group group_id="P3">
          <title>Placebo in TP2</title>
          <description>Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.</description>
        </group>
        <group group_id="P4">
          <title>AIN457 in TP3</title>
          <description>Treatment Period 3</description>
        </group>
        <group group_id="P5">
          <title>Placebo in TP 3</title>
          <description>Treatment Period 3</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Treatment Period 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <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_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <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_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <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_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <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_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="38"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="36"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</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="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Treatment Period 3</title>
          <milestone_list>
            <milestone>
              <title>STARTED</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="11"/>
                <participants group_id="P5" count="0"/>
              </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="10"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT 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="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Set included subjects who received any treatment. TP1 = 86, TP2 = 75</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. At Week 12 (end of TP1), subject's response to study drug was determined (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="86"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>Safety Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>AIN457 in Treatment Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="37"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>placebo in TP2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="38"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <description>Mean age of participants in years&#xD;
ERA + JPsA = Total</description>
          <population>Safety Set</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>AIN457 in Treatment Period 1 - JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.7" spread="2.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 1 - JIA Category: JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12.2" spread="3.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 2 - JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14" spread="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 2 - JIA Category: JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.1" spread="3.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Placebo in TP2- JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13" spread="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Placebo in TP2 - JIA Category JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.6" spread="3.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>ERA + JPsA = Total</description>
          <population>Safety Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>AIN457 in Treatment Period 1 - JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 1 -JIA Category: JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 2 - JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 2 -JIA Category: JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Placebo in TP2 - JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Placebo in TP2 - JIA Category: JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>ERA + JPsA = Total&#xD;
Unknown or Not Reported Row also means &quot;Other&quot; (none of the above)</description>
          <population>Safety Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>AIN457 in Treatment Period 1 - JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 1 - JIA Category: JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 2 - JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AIN457 in Treatment Period 2 - JIA Category: JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Placebo in TP2 - JIA Category: ERA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Placebo in TP2 - JIA Category: JPsA</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Experiencing a Flare During Treatment Period 2</title>
        <description>Survival analysis of time to flare in treatment period 2 (TP2) FAS2&#xD;
Subjects are either ERA or JPsA</description>
        <time_frame>From Week 12 until max Week 104</time_frame>
        <population>Full Analysis Set for TP2: The FAS TP2 (FAS 2) consisted of all randomized subjects who received at least one dose of study drug in TP2. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization in TP2.</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 2</title>
            <description>Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.</description>
          </group>
          <group group_id="O2">
            <title>Placebo in TP2</title>
            <description>Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing a Flare During Treatment Period 2</title>
          <description>Survival analysis of time to flare in treatment period 2 (TP2) FAS2&#xD;
Subjects are either ERA or JPsA</description>
          <population>Full Analysis Set for TP2: The FAS TP2 (FAS 2) consisted of all randomized subjects who received at least one dose of study drug in TP2. Following the intent-to-treat principle, subjects were analyzed according to the treatment they were assigned to at randomization in TP2.</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="37"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Survival analysis of time to flare - TP2 (FAS2)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Log Rank</method>
            <method_desc>Hazard ratios and associated 95% confidence intervals are based on a Cox proportional hazards model with treatment and analysis factors</method_desc>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.28</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category</title>
        <description>Summary of JIA ACR 30/50/70/90/100 for all subjects and each JIA category - TP1 (FAS1)&#xD;
The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components&#xD;
Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.&#xD;
Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.&#xD;
Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)&#xD;
Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)&#xD;
Number of joints with limitation of motion&#xD;
Laboratory measure of inflammation: CRP (mg/L)</description>
        <time_frame>baseline, week 12</time_frame>
        <population>Full Analysis Set for TP1: The FAS TP1 (FAS 1) consisted of all subjects who received at least one dose of study drug in TP1.</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1 - ERA</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
          <group group_id="O2">
            <title>AIN457 in Treatment Periiod 1 - JPsA</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;+ 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category</title>
          <description>Summary of JIA ACR 30/50/70/90/100 for all subjects and each JIA category - TP1 (FAS1)&#xD;
The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components&#xD;
Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.&#xD;
Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.&#xD;
Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)&#xD;
Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)&#xD;
Number of joints with limitation of motion&#xD;
Laboratory measure of inflammation: CRP (mg/L)</description>
          <population>Full Analysis Set for TP1: The FAS TP1 (FAS 1) consisted of all subjects who received at least one dose of study drug in TP1.</population>
          <units>percent 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="52"/>
                <count group_id="O2" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACR 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.3" lower_limit="73.1" upper_limit="93.8"/>
                    <measurement group_id="O2" value="96.9" lower_limit="82.0" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.4" lower_limit="66.5" upper_limit="89.7"/>
                    <measurement group_id="O2" value="96.9" lower_limit="82.0" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR 70</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="52.0" upper_limit="78.9"/>
                    <measurement group_id="O2" value="75.0" lower_limit="56.2" upper_limit="87.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR 90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="21.1" upper_limit="48.0"/>
                    <measurement group_id="O2" value="50.0" lower_limit="32.2" upper_limit="67.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.5" lower_limit="16.3" upper_limit="42.0"/>
                    <measurement group_id="O2" value="21.9" lower_limit="9.9" upper_limit="40.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total</title>
        <description>Summary of JIA ACR 30/50/70/90/100 for all subjects - TP1 (FAS1)&#xD;
The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components&#xD;
Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.&#xD;
Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.&#xD;
Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)&#xD;
Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)&#xD;
Number of joints with limitation of motion&#xD;
Laboratory measure of inflammation: CRP (mg/L)</description>
        <time_frame>baseline, week 12</time_frame>
        <population>Full Analysis Set for TP1: The FAS TP1 (FAS 1) consisted of all subjects who received at least one dose of study drug in TP1.</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1 - TOTAL</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total</title>
          <description>Summary of JIA ACR 30/50/70/90/100 for all subjects - TP1 (FAS1)&#xD;
The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components&#xD;
Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.&#xD;
Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.&#xD;
Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)&#xD;
Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)&#xD;
Number of joints with limitation of motion&#xD;
Laboratory measure of inflammation: CRP (mg/L)</description>
          <population>Full Analysis Set for TP1: The FAS TP1 (FAS 1) consisted of all subjects who received at least one dose of study drug in TP1.</population>
          <units>percent 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="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ACR 30</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.4" lower_limit="81.4" upper_limit="95.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR 50</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.7" lower_limit="77.1" upper_limit="92.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR 70</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.9" lower_limit="58.7" upper_limit="79.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR 90</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.8" lower_limit="29.4" upper_limit="51.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ACR 100</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" lower_limit="16.7" upper_limit="36.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline for JIA ACR Core Components in TP1</title>
        <description>Summary of JIA ACR core components for all subjects and each JIA category - Treatment period 1&#xD;
Negative percent change indicates improvement&#xD;
Physician global assessment of disease activity (VAS mm) 0 (no disease activity) - 100 (very severe); Parent or subject global assessment of overall well-being (VAS mm) 0 (very well) - 100 (very poor); CHAQ (Childhood Health Assessment Questionnaire) 0 - 3 (most severe); Number of joints with active arthritis 0 - 73; Number of joints with limited range of motion 0 - 69.</description>
        <time_frame>baseline, week 12</time_frame>
        <population>FAS TP1 including patients with valid measurements at week 12</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline for JIA ACR Core Components in TP1</title>
          <description>Summary of JIA ACR core components for all subjects and each JIA category - Treatment period 1&#xD;
Negative percent change indicates improvement&#xD;
Physician global assessment of disease activity (VAS mm) 0 (no disease activity) - 100 (very severe); Parent or subject global assessment of overall well-being (VAS mm) 0 (very well) - 100 (very poor); CHAQ (Childhood Health Assessment Questionnaire) 0 - 3 (most severe); Number of joints with active arthritis 0 - 73; Number of joints with limited range of motion 0 - 69.</description>
          <population>FAS TP1 including patients with valid measurements at week 12</population>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>physician global assessment of disease activity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-77.4" spread="22.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>parent/subject global assessment of overall well-being</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.1" spread="58.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>functional ability (CHAQ)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.776" spread="70.5034"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of joints with active arthritis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-79.3" spread="34.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of joints with limited range of motion</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-72.5" spread="38.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change in C-reactive Protein Standardized Value (mg/L)</title>
        <description>Median Percent Change from baseline for C-reactive protein standardized value (mg/L)</description>
        <time_frame>baseline, week 12</time_frame>
        <population>FAS TP1</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change in C-reactive Protein Standardized Value (mg/L)</title>
          <description>Median Percent Change from baseline for C-reactive protein standardized value (mg/L)</description>
          <population>FAS TP1</population>
          <units>percent change</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.587" spread="227.6901"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score</title>
        <description>JADAS change from baseline for all subjects in Treatment period 1. JADAS-27 (Juvenile Arthritis Disease Activity Score in 27 joints) ranges from 0 to 57 and JADAS-71 ranges from 0 to 101 (higher scores indicate more disease activity).</description>
        <time_frame>12 weeks</time_frame>
        <population>FAS treatment period 1</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score</title>
          <description>JADAS change from baseline for all subjects in Treatment period 1. JADAS-27 (Juvenile Arthritis Disease Activity Score in 27 joints) ranges from 0 to 57 and JADAS-71 ranges from 0 to 101 (higher scores indicate more disease activity).</description>
          <population>FAS treatment period 1</population>
          <units>score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>JADAS-27</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.487" spread="7.2262"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>JADAS-71</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.403" spread="9.7300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Enthesitis Events - TP1 (FAS1)</title>
        <description>Enthesitis swollen joint count range is 0-16. Zero is worst, and 16 is best&#xD;
A total of 16 entheseal sites were assessed for the presence or absence of tenderness of enthesitis.&#xD;
This is the mean (SD) enthesitis count (range 0-16) for FAS subjects&#xD;
A zero score means no enthesitis, so a zero score is better for the patient</description>
        <time_frame>Baseline and week 12</time_frame>
        <population>FAS TP1 including patients with valid measurements at week 12</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Enthesitis Events - TP1 (FAS1)</title>
          <description>Enthesitis swollen joint count range is 0-16. Zero is worst, and 16 is best&#xD;
A total of 16 entheseal sites were assessed for the presence or absence of tenderness of enthesitis.&#xD;
This is the mean (SD) enthesitis count (range 0-16) for FAS subjects&#xD;
A zero score means no enthesitis, so a zero score is better for the patient</description>
          <population>FAS TP1 including patients with valid measurements at week 12</population>
          <units>Number of enthesitis events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="2.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Dactylitis Count</title>
        <description>Summary of total dactylitis count for all subjects - TP1 (FAS1)&#xD;
Total dactylitis count ranges from 0 to 20. A zero score means no dactylitis, so a zero score is better for the patient</description>
        <time_frame>baseline, week 12</time_frame>
        <population>FAS TP1 including patients with valid measurements at week 12</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Dactylitis Count</title>
          <description>Summary of total dactylitis count for all subjects - TP1 (FAS1)&#xD;
Total dactylitis count ranges from 0 to 20. A zero score means no dactylitis, so a zero score is better for the patient</description>
          <population>FAS TP1 including patients with valid measurements at week 12</population>
          <units>Number of dactylitis events</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Anti-secukinumab Anitbodies</title>
        <description>Blood samples for immunogenicity (anti-AIN457 antibodies) were taken pre-dose at the scheduled time points. In addition, if a subject discontinued from the study at any time, he/she provided a sample at the last visit. All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. An Electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation.</description>
        <time_frame>104 weeks</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
          <group group_id="O2">
            <title>AIN457 in Treatment Period 2 - Active</title>
            <description>TP2 treatment withdrawal: Secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1</description>
          </group>
          <group group_id="O3">
            <title>Placebo TP2</title>
            <description>Placebo s.c. in Treatment Period 2: all subjects who took placebo in TP2 and AIN457 in other period/s</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Anti-secukinumab Anitbodies</title>
          <description>Blood samples for immunogenicity (anti-AIN457 antibodies) were taken pre-dose at the scheduled time points. In addition, if a subject discontinued from the study at any time, he/she provided a sample at the last visit. All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. An Electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation.</description>
          <population>FAS</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="86"/>
                <count group_id="O2" value="37"/>
                <count group_id="O3" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Secukinumab Serum Concentration</title>
        <description>Summary of pharmacokinetic concentrations - Treatment period 1</description>
        <time_frame>baseline, week 12</time_frame>
        <population>Safety Set</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1</title>
            <description>to week 12&#xD;
TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Secukinumab Serum Concentration</title>
          <description>Summary of pharmacokinetic concentrations - Treatment period 1</description>
          <population>Safety Set</population>
          <units>mcg/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;50 kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.9" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=50 kg</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Inactive Disease Status for All Subjects - TP1 (FAS1)</title>
        <description>Summary of inactive disease status for all subjects - TP1 (FAS1)&#xD;
Clinical inactive disease definition was adapted from the JIA ACR criteria.&#xD;
All were required to be met:&#xD;
No joints with active arthritis&#xD;
No uveitis&#xD;
CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA&#xD;
Physician's global assessment of disease activity score ≤ 10mm&#xD;
Duration of morning stiffness attributable to JIA ≤15 min</description>
        <time_frame>week 12</time_frame>
        <population>FAS1</population>
        <group_list>
          <group group_id="O1">
            <title>AIN457 in Treatment Period 1</title>
            <description>TP1 open-label: Secukinumab 75 mg or 150 mg based on the body weight (&lt;50 kg or &gt;= 50 kg) was administered s.c. end of TP1 visit at week 12 was determined based on subject's response to the study drug administered (responders entered TP2 and non-responders entered post-treatment follow-up)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Inactive Disease Status for All Subjects - TP1 (FAS1)</title>
          <description>Summary of inactive disease status for all subjects - TP1 (FAS1)&#xD;
Clinical inactive disease definition was adapted from the JIA ACR criteria.&#xD;
All were required to be met:&#xD;
No joints with active arthritis&#xD;
No uveitis&#xD;
CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA&#xD;
Physician's global assessment of disease activity score ≤ 10mm&#xD;
Duration of morning stiffness attributable to JIA ≤15 min</description>
          <population>FAS1</population>
          <units>partcipants</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="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="26.1" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events (AEs) were collected from the time patient provided informed consent until the end of study. Serious Adverse Events (SAEs) were collected after the patient provided informed consent and until 12 weeks after last administered dose of study treatment or 30 days after the subject has stopped study participation (whichever is later)</time_frame>
      <desc>AEs are any untoward sign or symptom that occurred during the study treatment period.&#xD;
AEs are presented across all three treatment periods combined since due to the study design, the exposure times for Placebo (only received in TP2) and Secukinumab were different over the entire treatment period. In addition, it cannot be ruled-out that events occurring in TP2 under placebo are due to a spill-over effect by the previous secukinumab treatment in TP1</desc>
      <group_list>
        <group group_id="E1">
          <title>AIN457 in Entire Treatment Period</title>
          <description>Includes all participants who did not receive placebo, i.e. either did not enter TP2 or were randomized to AIN457 in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.</description>
        </group>
        <group group_id="E2">
          <title>Placebo in TP2</title>
          <description>Includes all participants who received placebo, i.e. were randomized to Placebo in TP2. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined, i.e. also including AEs that occurred when treated with AIN457 in TP1 or TP3.</description>
        </group>
        <group group_id="E3">
          <title>Total</title>
          <description>Includes all participants who were treated with study medication. In this arm, AEs are reported for all three treatment periods (TP1, TP2 and TP3) combined.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Crohn's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Juvenile psoriatic arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cholesteatoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Adenoidal hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="79" subjects_at_risk="86"/>
              </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="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Iron deficiency anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Gilbert's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Hydrocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Eye haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Myopia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Uveitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Functional gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Lip disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Malpositioned teeth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Noninfective gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Oral mucosal blistering</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Salivary hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Administration site reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Medical device pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Nonalcoholic fatty liver disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Mite allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Adenoiditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Enterobiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Helminthic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Nail bed infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Nail infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Onychomycosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Oral viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pulpitis dental</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Soft tissue infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Gingival injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Injection related reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Ligament rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Venomous sting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood calcium increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood phosphorus increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood pressure systolic increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood triglycerides increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blood uric acid increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Eosinophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Liver function test increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Platelet count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>White blood cells urine positive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </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="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Lactose intolerance</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Enthesopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Jaw disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Juvenile psoriatic arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Muscle contracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Temporomandibular joint syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Papilloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Skin papilloma</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Visual field defect</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Distractibility</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Euphoric mood</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Intentional self-injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Mental disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Post-traumatic stress disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Renal colic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Gynaecomastia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Menstruation irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Scrotal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Varicocele</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Diffuse alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Dyshidrotic eczema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Exfoliative rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Ingrowing nail</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Skin erosion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Skin plaque</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Skin striae</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Sexual abuse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Cyanosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="48"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Novartis Pharmaceuticals</organization>
      <phone>(862) 778-8300</phone>
      <email>novartis.email@novartis.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03031782
org study id: CAIN457F2304
secondary id: 2016-003761-26
nct id: NCT03031782
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This was a double-blind, placebo-controlled, event-driven randomized withdrawal study to
      investigate the efficacy and safety of secukinumab treatment in the Juvenile Idiopathic
      Arthritis (JIA) categories of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis-related
      Arthritis (ERA). The study was divided into 3 parts (plus a post-treatment follow-up period)
      consisting of open-label, single-arm active treatment in Treatment Periods 1 and 3 and a
      randomized, double-blind, placebo controlled, event-driven withdrawal design in Treatment
      Period 2
TP1: All eligible subjects entered TP1 to receive 12-weeks of open-label secukinumab at a
      dose predicted to achieve secukinumab serum levels equivalent to adults administered a 150 mg
      dose regimen. Secukinumab was administered s.c. weekly for the first 4 weeks (Baseline, Weeks
      1, 2, 3, 4) and then every 4 weeks thereafter. Clinical response (JIA ACR 30) was assessed at
      Week 12. Responders advanced to TP2 and non-responders exited the trial (early termination
      visit and entered into the Post-treatment follow-up period).

      TP2: Subjects who were a responder (JIA ACR 30) at Week 12 entered the double-blind
      withdrawal TP2 and were randomized 1:1 to either secukinumab or placebo on that visit and
      then every 4 weeks, until either experiencing a disease flare or completion of TP2. TP2 was
      event driven and was planned to be closed when 33 subjects experienced a disease flare as per
      JIA definition. Alternatively, the study could be closed when all subjects reached the total
      study duration of 104 Weeks and therefore subjects who did not experience a disease flare
      remained in TP2 for the duration of the study and completed the study without entering into
      TP3

      TP3: Subjects experiencing a disease flare in TP2 immediately entered TP3 to receive
      openlabel secukinumab every 4 weeks until total study duration of 104 weeks for that subject
      was achieved.

      Post-treatment follow-up: The post-treatment follow-up period (lasting 12 weeks from the last
      study drug administration) was required for all subjects, unless they qualified and entered
      the secukinumab extension trial. All subjects were expected to participate in the
      post-treatment follow up period, except for those entering the extension study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants Experiencing a Flare During Treatment Period 2
time frame: From Week 12 until max Week 104
description: Survival analysis of time to flare in treatment period 2 (TP2) FAS2
Subjects are either ERA or JPsA
measure: Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - by JIA Category
time frame: baseline, week 12
description: Summary of JIA ACR 30/50/70/90/100 for all subjects and each JIA category - TP1 (FAS1)
The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components
Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.
Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.
Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)
Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)
Number of joints with limitation of motion
Laboratory measure of inflammation: CRP (mg/L)
measure: Percent of Participants With Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30/50/70/90/100 Response at Week 12 - Total
time frame: baseline, week 12
description: Summary of JIA ACR 30/50/70/90/100 for all subjects - TP1 (FAS1)
The adapted ACR Pediatric 30/50/70/90/100 criteria was used to determine efficacy defined as improvement from baseline of at least 30/50/70/90/100% respectively in at least 3 of the following 6 components
Physician's Global Assessment of disease activity on a 0-100 mm VAS from 0 mm = no disease activity to 100 mm = very severe disease activity.
Parent's or patient's Global Assessment of Subject's overall wellbeing on a 0-100 mm VAS from 0 mm= very well to 100 mm= very poor.
Functional ability: Childhood Health Assessment Questionnaire (CHAQ©)
Number of joints with active arthritis using the ACR definition (The ACR definition of active arthritis is any joint with swelling, or in the absence of swelling, limitation of motion accompanied by either pain on motion or tenderness not due to deformity)
Number of joints with limitation of motion
Laboratory measure of inflammation: CRP (mg/L)
measure: Percent Change From Baseline for JIA ACR Core Components in TP1
time frame: baseline, week 12
description: Summary of JIA ACR core components for all subjects and each JIA category - Treatment period 1
Negative percent change indicates improvement
Physician global assessment of disease activity (VAS mm) 0 (no disease activity) - 100 (very severe); Parent or subject global assessment of overall well-being (VAS mm) 0 (very well) - 100 (very poor); CHAQ (Childhood Health Assessment Questionnaire) 0 - 3 (most severe); Number of joints with active arthritis 0 - 73; Number of joints with limited range of motion 0 - 69.
measure: Percent Change in C-reactive Protein Standardized Value (mg/L)
time frame: baseline, week 12
description: Median Percent Change from baseline for C-reactive protein standardized value (mg/L)
measure: Change From Baseline Juvenile Arthritis Disease Activity Score (JADAS) Score
time frame: 12 weeks
description: JADAS change from baseline for all subjects in Treatment period 1. JADAS-27 (Juvenile Arthritis Disease Activity Score in 27 joints) ranges from 0 to 57 and JADAS-71 ranges from 0 to 101 (higher scores indicate more disease activity).
measure: Change From Baseline in Total Enthesitis Events - TP1 (FAS1)
time frame: Baseline and week 12
description: Enthesitis swollen joint count range is 0-16. Zero is worst, and 16 is best
A total of 16 entheseal sites were assessed for the presence or absence of tenderness of enthesitis.
This is the mean (SD) enthesitis count (range 0-16) for FAS subjects
A zero score means no enthesitis, so a zero score is better for the patient
measure: Change From Baseline in Total Dactylitis Count
time frame: baseline, week 12
description: Summary of total dactylitis count for all subjects - TP1 (FAS1)
Total dactylitis count ranges from 0 to 20. A zero score means no dactylitis, so a zero score is better for the patient
measure: Number of Participants With Anti-secukinumab Anitbodies
time frame: 104 weeks
description: Blood samples for immunogenicity (anti-AIN457 antibodies) were taken pre-dose at the scheduled time points. In addition, if a subject discontinued from the study at any time, he/she provided a sample at the last visit. All blood samples were taken by either direct venipuncture or an indwelling cannula inserted in a forearm vein. An Electrochemiluminescence method was used for the detection of potential anti-secukinumab antibody formation.
measure: Secukinumab Serum Concentration
time frame: baseline, week 12
description: Summary of pharmacokinetic concentrations - Treatment period 1
measure: Number of Participants With Inactive Disease Status for All Subjects - TP1 (FAS1)
time frame: week 12
description: Summary of inactive disease status for all subjects - TP1 (FAS1)
Clinical inactive disease definition was adapted from the JIA ACR criteria.
All were required to be met:
No joints with active arthritis
No uveitis
CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA
Physician's global assessment of disease activity score ≤ 10mm
Duration of morning stiffness attributable to JIA ≤15 min
arm group label: Treatment Period 2 - active
arm group type: Experimental
description: secukinumab (AIN457 - pre-filled syringe) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
arm group label: Treatment Period 2 - placebo
arm group type: Placebo Comparator
description: placebo comparator (matched to secukinumab treatment) for patients with a minimum American college of Rheumatology (ACR) 30 response in Treatment Period 1
intervention type: Drug
intervention name: secukinumab
description: secukinumab is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.
arm group label: Treatment Period 2 - active
other name: AIN457
intervention type: Other
intervention name: placebo
description: Matched placebo to AIN457 for use in the double blind Treatment Period 2
arm group label: Treatment Period 2 - placebo
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Belgium
country: Germany
country: Italy
country: Poland
country: Russian Federation
country: South Africa
country: Spain
country: Turkey
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Enthesopathy
mesh term: Arthritis, Juvenile
sharing ipd: Undecided
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
provided document: 
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participant flow: 
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reported events: 
certain agreements: 
point of contact: 