<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/NCT02204293</url>
  </required_header>
  <id_info>
    <org_study_id>CACZ885GDE01T</org_study_id>
    <secondary_id>2011-001027-20</secondary_id>
    <nct_id>NCT02204293</nct_id>
  </id_info>
  <brief_title>Canakinumab for Treatment of Adult-onset Still's Disease</brief_title>
  <acronym>CONSIDER</acronym>
  <official_title>Study Protocol for a Multi-Centre, Placebo-Controlled Phase II Study of Canakinumab for the Treatment of Adult-onset Still's Disease (AOSD) Including an Open-label Long Term Extension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to investigate the efficacy of the treatment with canakinumab in&#xD;
      participants with Adult-onset Still's Disease (AOSD) and active joint involvement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruitment issues due to marketing authorization of study drug&#xD;
  </why_stopped>
  <start_date type="Actual">June 21, 2012</start_date>
  <completion_date type="Actual">May 5, 2018</completion_date>
  <primary_completion_date type="Actual">May 5, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>Responders included participants with change in disease activity score based on 28 joint counts and ESR (DAS28) score &gt; 1.2. The DAS28 score index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and the erythrocyte sedimentation rate (ESR) value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and ESR value.Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Least squares (LS) mean was calculated by mixed linear model for repeated measures (MMRM) analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC)</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>The 68 TJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no tender joint) to 68 (all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC)</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>The 66 SJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no swollen joint) to 66 (all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. A negative change in Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in the 28 TJC</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in the 28 SJC</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>A total of 28 joints were assessed for swelling. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>A negative change from Baseline in CRP level indicates an improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>A negative change from Baseline in ESR level indicates an improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in Serum Ferritin Level at Week 12</measure>
    <time_frame>Week 12</time_frame>
    <description>LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders With Fever Episodes</measure>
    <time_frame>Week 12</time_frame>
    <description>Fever is defined as an oral or rectal body temperature greater than 38 degrees Celsius (°C).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>The physician's global assessment of disease activity was assessed using a numerical rating scale of 0-10 where 0= no disease activity and 10= activity to maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>The participant's global assessment of disease activity was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score</measure>
    <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
    <description>The participant's global assessment of pain was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders With American College of Rheumatology Response of 20 (ACR20)</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>ACR20 response was defined as a ≥ 20% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders With ACR30</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>ACR30 response was defined as a ≥ 30% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders With Modified ACR30</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>A participant was considered responder if he/she had achieved the incidence of modified adapted response (ACR30 criteria) of at least a 30% improvement in no intermittent fever and had at least 30% improvement in at least 6 of the following 7 measures: tender and swollen 68-joint counts, participant's assessment of pain, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's functional capacity (HAQ-DI score) and acute phase reactant- ESR. Participant were modified ACR30 responders at a given post-randomization visit if they satisfied the modified ACR30 criteria, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders With ACR50</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>ACR50 response was defined as a ≥ 50% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders With ACR70</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>ACR70 response was defined as a ≥ 70% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders With ACR90</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>ACR90 response was defined as a ≥ 90% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders With European League Against Rheumatism (EULAR) Response</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>EULAR response is based on DAS28-ESR and DAS28-CRP scores. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, subject global assessment of disease activity score, and ESR or CRP value. A DAS28-CRP or ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. EULAR response has 3 categories: EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline &lt; -1.2. EULAR Moderate response: DAS28 &gt;3.2 to ≤ 5.1 or a change from Baseline &lt; -0.6 to ≥ -1.2 or EULAR No response: DAS28 &gt;5.1 or a change from Baseline &lt; -0.6 to ≤ -1.2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders Achieving Low Disease Activity (LDA)</measure>
    <time_frame>Week 12</time_frame>
    <description>Percentage of responders were defined as the participants who achieved LDA (DAS28 score &lt; 3.2) at Week 12. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR or CRP value. Total score ranged between 0-10. A DAS28 score greater than 5.1 implies high disease activity, equal to or less than 3.2 low disease activity, and less than 2.6 remissions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission</measure>
    <time_frame>Week 12</time_frame>
    <description>Participants with disease remission: LDA (DAS28 score&lt; 2.6). The DAS28 index is a composite score of weighted components including both 28 TJC an SJC, participant global assessment of disease activity score, and ESR or CRP value. A DAS28 score greater than 5.1: high disease activity, ≤ 3.2: low disease activity, and less than 2.6: remission. Extended remission criteria included DAS28 &lt; 2.6 and no signs of systemic activity for up to two consecutive study visits till Week 12 defined as any of Yamaguchi´s primary classification criteria for AOSD which included fever attacks at 39 °C for more than a week, arthralgia, salmon red, maculate, urticarial or maculo-papular rash and leukocytosis (white blood cells increase) of &gt; 10000/cubic millimeters (mm^3) with &gt; 80% neutrophils.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: Change in Joint Mobility (Degrees of Motion) Assessed by Neutral Zero Method</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>Number of joints with limitation of motion according to neutral zero method was assessed which included mobility of joints (elbows, wrists, shoulder joints, hip joints, knee joints, and upper ankle joints) within the reference range/degree. Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from Baseline. A negative change score indicates improvement. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score</measure>
    <time_frame>Baseline, Week 12</time_frame>
    <description>The SF-36 determines overall quality of life assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 contribute to physical component summary score (PCS). Items 5-8 contribute to mental component summary score (MCS). Scores on each item are summed and averaged (range = 0 &quot;worst&quot;-100 &quot;best&quot;). Positive numbers indicate improvement from Baseline. LS mean was calculated by MMRM analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to Month 27</time_frame>
    <description>An AE is an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. AEs include symptoms of illnesses, as well as every unfavourable and unintended reaction. SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Adult-Onset Still´s Disease</condition>
  <arm_group>
    <arm_group_label>Canakinumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received canakinumab 4 mg/kg up to a maximum of 300 mg subcutaneous (SC) injection, once in morning on Day 0, Weeks 4, 8, and 12 in Part I of the core study. Participants with response (change in DAS score &gt; 1.2 at Week 12) continued to receive same dose of canakinumab in Part II for Weeks 12, 16, and 20. Participants who had remission (change in DAS score &gt; 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) entered Long-term extension (LTE) phase and received same dose of canakinumab at Weeks 24 and 28, which was down titrated to 2 mg/kg if applicable from Week 28 up to Month 27.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo, SC injection, once in morning on Day 0, Weeks 4, 8, and 12 in Part I of the core study. Participants with response (change in DAS score &gt; 1.2 at Week 12) continued to receive placebo at Weeks 12, 16, and 20. Non-responders (who had change in DAS score ≤ 1.2) were unblinded to receive canakinumab 4 mg/kg (up to 300 mg maximum), SC injection, at Weeks 12, 16, and 20. Participants who had remission (change in DAS score &gt; 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) entered Long-term extension (LTE) phase and received same dose of canakinumab at Weeks 24 and 28, which was down titrated to 2 mg/kg if applicable from Week 28 up to Month 27.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Canakinumab</intervention_name>
    <description>Canakinumab, single-dose 4 mg/kg up to 300 mg administered subcutaneously.</description>
    <arm_group_label>Canakinumab</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Ilaris</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matching placebo administered subcutaneously.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written and signed consent from the participant to take part in the study&#xD;
&#xD;
          2. Men and women aged ≥ 18 years and ≤ 75 years&#xD;
&#xD;
          3. Fulfilment of AOSD classification criteria (according to Yamaguchi et al, J.&#xD;
             Rheumatology, 1992)&#xD;
&#xD;
          4. Disease activity based on Disease Activity Score 28 (DAS28) of ≥3.2 at screening&#xD;
&#xD;
          5. At least 4 painful and 4 swollen joints at screening and baseline (of the 28 joints&#xD;
             according to DAS28)&#xD;
&#xD;
          6. If undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), stable&#xD;
             dose for at least 4 weeks prior to randomisation&#xD;
&#xD;
          7. If undergoing treatment with glucocorticoids, stable dose of ≤10 milligrams per day&#xD;
             (mg/day) (prednisolone or equivalent) for at least 4 weeks prior to randomisation&#xD;
&#xD;
          8. If undergoing treatment with conventional disease-modifying anti-rheumatic drugs&#xD;
             (DMARD), stable dose for at least 3 months prior to randomisation&#xD;
&#xD;
          9. Normalisation period for biological DMARDS (anakinra 1 week, etanercept 1 month,&#xD;
             adalimumab and certolizumab 2 months, infliximab, golimumab, abatacept and tocilizumab&#xD;
             3 months, rituximab 9 months, canakinumab 6 months) prior to randomisation&#xD;
&#xD;
         10. In participants of reproductive age, use of an effective method of contraception as&#xD;
             well as negative pregnancy test prior to the study commencing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous treatment with the study drug with repeated administration of canakinumab&#xD;
&#xD;
          2. Intraarticular or intravenous administration of glucocorticoids within 4 weeks prior&#xD;
             to the baseline or use of narcotic analgesics except for analgesics permitted within&#xD;
             the framework of the investigation (codeine and tramadol)&#xD;
&#xD;
          3. Presence of another, serious chronic-inflammatory disease&#xD;
&#xD;
          4. Positive hepatitis B antigen (HBsAg), hepatitis C antibodies and/or human&#xD;
             immunodeficiency virus (HIV) antibodies.&#xD;
&#xD;
          5. Presence of a relevant, active infection or other diseases, which entail a tendency&#xD;
             towards infection&#xD;
&#xD;
          6. Positive screening for latent tuberculosis, in accordance with usual local practice&#xD;
&#xD;
          7. Raised liver count (raised bilirubin; alanine aminotransferase (ALT) or aspartate&#xD;
             aminotransferase (AST) ≥ 3-fold the normal range)&#xD;
&#xD;
          8. Serum-creatinine concentration &gt;1.5 milligrams per deciliter (mg/dL)&#xD;
&#xD;
          9. Inadequate haematological findings (hemoglobin [Hb] ≤ 10 grams per deciliter (g/dL),&#xD;
             neutrophils ≤2,500/microliter (µl) and thrombocytes ≤100,000/µl)&#xD;
&#xD;
         10. Simultaneous participation in any other interventional clinical study within the last&#xD;
             30 days preceding the commencement of the study&#xD;
&#xD;
         11. History of neoplasia with the exception of a curatively treated non-melanoma skin&#xD;
             tumour or carcinoma of the cervix treated in situ without any indication of recurrence&#xD;
             within the last 10 years&#xD;
&#xD;
         12. Relevant cardiac or pulmonary disorders&#xD;
&#xD;
         13. Severe intercurrent neurological or psychiatric disorders&#xD;
&#xD;
         14. Macrophage activation syndrome (MAS) as part of previous treatment with IL-1 blockade&#xD;
             (e.g. anakinra, rilonacept)&#xD;
&#xD;
         15. Vaccination with a live vaccine within 3 months before the baseline&#xD;
&#xD;
         16. Alcohol or drug abuse in the past 12 months&#xD;
&#xD;
         17. ≥400 milliliter (mL) donation of blood or loss up to 8 weeks before the baseline&#xD;
&#xD;
         18. Pregnancy or breast-feeding&#xD;
&#xD;
         19. Commitment of the patient to an institution at the direction of an authority or court&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eugen Feist, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Charité University Berlin Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Charité Campus Mitte</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Immanuel Krankenhaus Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universität Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Essen-Süd/Krankenhaus St. Josef</name>
      <address>
        <city>Essen</city>
        <zip>45239</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum der J.W. Goethe-Universität Frankfurt</name>
      <address>
        <city>Frankfurt a. M.</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinikum Hamburg Altona</name>
      <address>
        <city>Hamburg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätskrankenhaus Schleswig Holstein</name>
      <address>
        <city>Kiel</city>
        <zip>24105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Med. Klinik I für Innere Medizin Köln</name>
      <address>
        <city>Köln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität München</name>
      <address>
        <city>München</city>
        <zip>80336</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Südstadt Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18059</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fachkrankenhaus</name>
      <address>
        <city>Vogelsang</city>
        <zip>39245</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://ard.bmj.com/content/early/2020/05/13/annrheumdis-2020-217155</url>
    <description>Related Info</description>
  </link>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <results_first_submitted>July 17, 2020</results_first_submitted>
  <results_first_submitted_qc>July 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 7, 2020</results_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Eugen Feist</investigator_full_name>
    <investigator_title>Prof. Dr Eugen Feist</investigator_title>
  </responsible_party>
  <keyword>Adult-Onset Still´s Disease</keyword>
  <keyword>Canakinumab</keyword>
  <keyword>Joint involvement</keyword>
  <keyword>AOSD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis, Juvenile</mesh_term>
    <mesh_term>Still's Disease, Adult-Onset</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>October 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT02204293/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>May 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT02204293/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants with adult-onset Still's disease (AOSD) took part in the study from June 21, 2012 to May 5, 2018 at 14 investigative sites located in Germany to participate in two double-blind parts - Part I (Up to Week 12) and Part II (Up to Week 24) and one open-label Long-Term Extension (LTE) phase (Up to Month 27).</recruitment_details>
      <pre_assignment_details>A total of 36 participants entered in Part I to receive canakinumab/placebo. Out of 31, 5 participants from canakinumab arm, and 3 from placebo arm did not enter Part II, 23 participants entered Part II and received canakinumab or placebo up to Week 24. 7 participants who achieved clinical remission entered LTE Phase to receive canakinumab.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Core Study Part I: Canakinumab</title>
          <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
        </group>
        <group group_id="P2">
          <title>Core Study Part I: Placebo</title>
          <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
        </group>
        <group group_id="P3">
          <title>Core Study Part II: Canakinumab Responders</title>
          <description>Participants with response (change in DAS score &gt; 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.</description>
        </group>
        <group group_id="P4">
          <title>Core Study Part II: Placebo Responders</title>
          <description>Participants with response (change in DAS score &gt; 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.</description>
        </group>
        <group group_id="P5">
          <title>Core Study Part II: Placebo Non-responders</title>
          <description>Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.</description>
        </group>
        <group group_id="P6">
          <title>LTE Phase: Canakinumab</title>
          <description>Participants with remission (change in DAS score &gt; 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Core Study Part I</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intention-to-treat Population</title>
              <participants_list>
                <participants group_id="P1" count="18">One participant left the study before treatment was started.</participants>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="20">2 participants from placebo arm received canakinumab at Week 4, included in Safety population.</participants>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Met one or more exclusion criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</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="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Core Study Part 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0">Participants who achieved response at Week 12, entered Part II.</participants>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="12">Participants who achieved response at Week 12, entered Part II.</participants>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Population</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="14">Included 2 participants from placebo arm who received canakinumab at Week 4.</participants>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" 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="12"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="7"/>
                <participants group_id="P6" 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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>LTE Phase</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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_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="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study Suspended</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intention-to-treat (ITT) population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
      <group_list>
        <group group_id="B1">
          <title>Core Study Part I: Canakinumab</title>
          <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
        </group>
        <group group_id="B2">
          <title>Core Study Part I: Placebo</title>
          <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="35"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41.06" spread="13.2"/>
                    <measurement group_id="B2" value="40.53" spread="13.2"/>
                    <measurement group_id="B3" value="40.79" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="17"/>
                    <count group_id="B3" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12</title>
        <description>Responders included participants with change in disease activity score based on 28 joint counts and ESR (DAS28) score &gt; 1.2. The DAS28 score index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and the erythrocyte sedimentation rate (ESR) value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission.</description>
        <time_frame>Week 12</time_frame>
        <population>Intention-to-treat (ITT) population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12</title>
          <description>Responders included participants with change in disease activity score based on 28 joint counts and ESR (DAS28) score &gt; 1.2. The DAS28 score index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and the erythrocyte sedimentation rate (ESR) value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission.</description>
          <population>Intention-to-treat (ITT) population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.7" lower_limit="43.1" upper_limit="85.2"/>
                    <measurement group_id="O2" value="41.2" lower_limit="20.1" upper_limit="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.1811</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score</title>
        <description>The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and ESR value.Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Least squares (LS) mean was calculated by mixed linear model for repeated measures (MMRM) analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score</title>
          <description>The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and ESR value.Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Least squares (LS) mean was calculated by mixed linear model for repeated measures (MMRM) analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.37" lower_limit="4.7" upper_limit="6.0"/>
                    <measurement group_id="O2" value="5.3" lower_limit="4.6" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.56" lower_limit="2.9" upper_limit="4.3"/>
                    <measurement group_id="O2" value="4.27" lower_limit="3.5" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" lower_limit="2.2" upper_limit="3.6"/>
                    <measurement group_id="O2" value="3.92" lower_limit="3.1" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="2.4" upper_limit="3.8"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.3" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score</title>
        <description>The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score</title>
          <description>The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.4" upper_limit="5.6"/>
                    <measurement group_id="O2" value="5.07" lower_limit="4.4" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="2.8" upper_limit="4.0"/>
                    <measurement group_id="O2" value="4.01" lower_limit="3.3" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.2" upper_limit="3.4"/>
                    <measurement group_id="O2" value="3.81" lower_limit="3.1" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.31" lower_limit="2.7" upper_limit="3.9"/>
                    <measurement group_id="O2" value="4.01" lower_limit="3.3" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC)</title>
        <description>The 68 TJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no tender joint) to 68 (all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC)</title>
          <description>The 68 TJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no tender joint) to 68 (all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>tender joints</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.89" lower_limit="4.9" upper_limit="12.9"/>
                    <measurement group_id="O2" value="11.18" lower_limit="7.1" upper_limit="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.33" lower_limit="1.3" upper_limit="9.3"/>
                    <measurement group_id="O2" value="5.85" lower_limit="1.5" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.72" lower_limit="-0.3" upper_limit="7.7"/>
                    <measurement group_id="O2" value="5.1" lower_limit="0.6" upper_limit="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.66" lower_limit="0.6" upper_limit="8.7"/>
                    <measurement group_id="O2" value="6.9" lower_limit="2.6" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC)</title>
        <description>The 66 SJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no swollen joint) to 66 (all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. A negative change in Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC)</title>
          <description>The 66 SJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no swollen joint) to 66 (all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. A negative change in Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>swollen joints</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.78" lower_limit="3.6" upper_limit="7.9"/>
                    <measurement group_id="O2" value="8.0" lower_limit="5.8" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="0.4" upper_limit="4.6"/>
                    <measurement group_id="O2" value="2.5" lower_limit="0.1" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.33" lower_limit="-0.8" upper_limit="3.5"/>
                    <measurement group_id="O2" value="2.65" lower_limit="0.2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.89" lower_limit="0.7" upper_limit="5.1"/>
                    <measurement group_id="O2" value="4.71" lower_limit="2.4" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in the 28 TJC</title>
        <description>A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in the 28 TJC</title>
          <description>A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>tender joints</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.78" lower_limit="4.6" upper_limit="9.0"/>
                    <measurement group_id="O2" value="7.24" lower_limit="5.0" upper_limit="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67" lower_limit="1.5" upper_limit="5.9"/>
                    <measurement group_id="O2" value="4.29" lower_limit="1.9" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.39" lower_limit="0.2" upper_limit="4.6"/>
                    <measurement group_id="O2" value="3.85" lower_limit="1.4" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.47" lower_limit="1.2" upper_limit="5.7"/>
                    <measurement group_id="O2" value="4.43" lower_limit="2.1" upper_limit="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in the 28 SJC</title>
        <description>A total of 28 joints were assessed for swelling. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in the 28 SJC</title>
          <description>A total of 28 joints were assessed for swelling. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>swollen joints</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.97" lower_limit="3.4" upper_limit="6.6"/>
                    <measurement group_id="O2" value="6.29" lower_limit="4.6" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.11" lower_limit="0.5" upper_limit="3.7"/>
                    <measurement group_id="O2" value="2.47" lower_limit="0.7" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.83" lower_limit="-0.8" upper_limit="2.5"/>
                    <measurement group_id="O2" value="2.79" lower_limit="1.0" upper_limit="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.28" lower_limit="0.6" upper_limit="3.9"/>
                    <measurement group_id="O2" value="4.51" lower_limit="2.8" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP</title>
        <description>A negative change from Baseline in CRP level indicates an improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP</title>
          <description>A negative change from Baseline in CRP level indicates an improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>milligrams per liter (mg/L)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.55" lower_limit="26.1" upper_limit="65.0"/>
                    <measurement group_id="O2" value="57.26" lower_limit="37.3" upper_limit="77.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.53" lower_limit="-2.1" upper_limit="37.1"/>
                    <measurement group_id="O2" value="36.74" lower_limit="15.8" upper_limit="57.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.61" lower_limit="-4.8" upper_limit="34.0"/>
                    <measurement group_id="O2" value="32.51" lower_limit="11.2" upper_limit="53.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.05" lower_limit="-2.6" upper_limit="36.7"/>
                    <measurement group_id="O2" value="28.52" lower_limit="7.0" upper_limit="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR</title>
        <description>A negative change from Baseline in ESR level indicates an improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR</title>
          <description>A negative change from Baseline in ESR level indicates an improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>millimeter per hour (mm/h)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.11" lower_limit="33.8" upper_limit="54.4"/>
                    <measurement group_id="O2" value="38.82" lower_limit="28.3" upper_limit="49.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.28" lower_limit="13.8" upper_limit="34.7"/>
                    <measurement group_id="O2" value="38.6" lower_limit="27.5" upper_limit="49.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.4" lower_limit="15.0" upper_limit="35.8"/>
                    <measurement group_id="O2" value="25.25" lower_limit="13.6" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.85" lower_limit="5.3" upper_limit="26.4"/>
                    <measurement group_id="O2" value="22.41" lower_limit="10.8" upper_limit="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in Serum Ferritin Level at Week 12</title>
        <description>LS mean was calculated by MMRM analyses.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in Serum Ferritin Level at Week 12</title>
          <description>LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>nanograms per milliliter (ng/mL)</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="466.9" lower_limit="16.0" upper_limit="918.0"/>
                    <measurement group_id="O2" value="634.71" lower_limit="170.0" upper_limit="1099.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders With Fever Episodes</title>
        <description>Fever is defined as an oral or rectal body temperature greater than 38 degrees Celsius (°C).</description>
        <time_frame>Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders With Fever Episodes</title>
          <description>Fever is defined as an oral or rectal body temperature greater than 38 degrees Celsius (°C).</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score</title>
        <description>The physician's global assessment of disease activity was assessed using a numerical rating scale of 0-10 where 0= no disease activity and 10= activity to maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score</title>
          <description>The physician's global assessment of disease activity was assessed using a numerical rating scale of 0-10 where 0= no disease activity and 10= activity to maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4.5" upper_limit="6.5"/>
                    <measurement group_id="O2" value="6.0" lower_limit="4.9" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.06" lower_limit="2.0" upper_limit="4.1"/>
                    <measurement group_id="O2" value="3.67" lower_limit="2.5" upper_limit="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.72" lower_limit="1.7" upper_limit="3.8"/>
                    <measurement group_id="O2" value="3.56" lower_limit="2.4" upper_limit="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" lower_limit="1.8" upper_limit="3.9"/>
                    <measurement group_id="O2" value="4.26" lower_limit="3.1" upper_limit="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score</title>
        <description>The participant's global assessment of disease activity was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score</title>
          <description>The participant's global assessment of disease activity was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.08" lower_limit="4.9" upper_limit="7.3"/>
                    <measurement group_id="O2" value="5.85" lower_limit="4.6" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.78" lower_limit="2.6" upper_limit="5.0"/>
                    <measurement group_id="O2" value="4.74" lower_limit="3.4" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.84" lower_limit="1.6" upper_limit="4.0"/>
                    <measurement group_id="O2" value="4.58" lower_limit="3.2" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.63" lower_limit="2.4" upper_limit="4.8"/>
                    <measurement group_id="O2" value="4.32" lower_limit="3.0" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score</title>
        <description>The participant's global assessment of pain was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Weeks 4, 8 and 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score</title>
          <description>The participant's global assessment of pain was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.61" lower_limit="5.3" upper_limit="7.9"/>
                    <measurement group_id="O2" value="6.35" lower_limit="5.0" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.61" lower_limit="2.3" upper_limit="4.9"/>
                    <measurement group_id="O2" value="4.85" lower_limit="3.5" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" lower_limit="1.4" upper_limit="4.0"/>
                    <measurement group_id="O2" value="4.18" lower_limit="2.7" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.71" lower_limit="2.4" upper_limit="5.0"/>
                    <measurement group_id="O2" value="4.25" lower_limit="2.8" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
        <description>The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score</title>
          <description>The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.31" lower_limit="0.9" upper_limit="1.7"/>
                    <measurement group_id="O2" value="1.29" lower_limit="0.9" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" lower_limit="0.3" upper_limit="1.1"/>
                    <measurement group_id="O2" value="0.98" lower_limit="0.6" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders With American College of Rheumatology Response of 20 (ACR20)</title>
        <description>ACR20 response was defined as a ≥ 20% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders With American College of Rheumatology Response of 20 (ACR20)</title>
          <description>ACR20 response was defined as a ≥ 20% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.1" lower_limit="37.7" upper_limit="81.1"/>
                    <measurement group_id="O2" value="41.2" lower_limit="20.1" upper_limit="65.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.3175</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>19.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.0</ci_lower_limit>
            <ci_upper_limit>51.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders With ACR30</title>
        <description>ACR30 response was defined as a ≥ 30% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders With ACR30</title>
          <description>ACR30 response was defined as a ≥ 30% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.1" lower_limit="37.7" upper_limit="81.1"/>
                    <measurement group_id="O2" value="29.4" lower_limit="11.7" upper_limit="53.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.0922</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>31.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.9</ci_lower_limit>
            <ci_upper_limit>61.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders With Modified ACR30</title>
        <description>A participant was considered responder if he/she had achieved the incidence of modified adapted response (ACR30 criteria) of at least a 30% improvement in no intermittent fever and had at least 30% improvement in at least 6 of the following 7 measures: tender and swollen 68-joint counts, participant's assessment of pain, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's functional capacity (HAQ-DI score) and acute phase reactant- ESR. Participant were modified ACR30 responders at a given post-randomization visit if they satisfied the modified ACR30 criteria, respectively.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders With Modified ACR30</title>
          <description>A participant was considered responder if he/she had achieved the incidence of modified adapted response (ACR30 criteria) of at least a 30% improvement in no intermittent fever and had at least 30% improvement in at least 6 of the following 7 measures: tender and swollen 68-joint counts, participant's assessment of pain, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's functional capacity (HAQ-DI score) and acute phase reactant- ESR. Participant were modified ACR30 responders at a given post-randomization visit if they satisfied the modified ACR30 criteria, respectively.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.6" lower_limit="32.7" upper_limit="76.8"/>
                    <measurement group_id="O2" value="23.5" lower_limit="8.0" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.0858</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>32.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.5</ci_lower_limit>
            <ci_upper_limit>61.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders With ACR50</title>
        <description>ACR50 response was defined as a ≥ 50% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders With ACR50</title>
          <description>ACR50 response was defined as a ≥ 50% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="27.8" upper_limit="72.2"/>
                    <measurement group_id="O2" value="17.6" lower_limit="4.7" upper_limit="40.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.075</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>32.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.7</ci_lower_limit>
            <ci_upper_limit>60.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders With ACR70</title>
        <description>ACR70 response was defined as a ≥ 70% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders With ACR70</title>
          <description>ACR70 response was defined as a ≥ 70% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="11.0" upper_limit="51.3"/>
                    <measurement group_id="O2" value="11.8" lower_limit="2.0" upper_limit="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.4018</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>16.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.6</ci_lower_limit>
            <ci_upper_limit>43.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders With ACR90</title>
        <description>ACR90 response was defined as a ≥ 90% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders With ACR90</title>
          <description>ACR90 response was defined as a ≥ 90% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="1.9" upper_limit="32.1"/>
                    <measurement group_id="O2" value="5.9" lower_limit="0.3" upper_limit="25.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>1</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>5.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.8</ci_lower_limit>
            <ci_upper_limit>29.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders With European League Against Rheumatism (EULAR) Response</title>
        <description>EULAR response is based on DAS28-ESR and DAS28-CRP scores. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, subject global assessment of disease activity score, and ESR or CRP value. A DAS28-CRP or ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. EULAR response has 3 categories: EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline &lt; -1.2. EULAR Moderate response: DAS28 &gt;3.2 to ≤ 5.1 or a change from Baseline &lt; -0.6 to ≥ -1.2 or EULAR No response: DAS28 &gt;5.1 or a change from Baseline &lt; -0.6 to ≤ -1.2.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders With European League Against Rheumatism (EULAR) Response</title>
          <description>EULAR response is based on DAS28-ESR and DAS28-CRP scores. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, subject global assessment of disease activity score, and ESR or CRP value. A DAS28-CRP or ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value &lt; 2.6 = disease remission. EULAR response has 3 categories: EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline &lt; -1.2. EULAR Moderate response: DAS28 &gt;3.2 to ≤ 5.1 or a change from Baseline &lt; -0.6 to ≥ -1.2 or EULAR No response: DAS28 &gt;5.1 or a change from Baseline &lt; -0.6 to ≤ -1.2.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>EULAR DAS28-ESR Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" lower_limit="54.7" upper_limit="92.5"/>
                    <measurement group_id="O2" value="52.9" lower_limit="29.7" upper_limit="75.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EULAR DAS28-CRP Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.2" lower_limit="48.7" upper_limit="89.0"/>
                    <measurement group_id="O2" value="47.1" lower_limit="24.8" upper_limit="70.3"/>
                  </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>EULAR DAS28-ESR Response</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.1642</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>24.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.0</ci_lower_limit>
            <ci_upper_limit>54.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>EULAR DAS28-CRP Response</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.1756</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>25.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.1</ci_lower_limit>
            <ci_upper_limit>55.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders Achieving Low Disease Activity (LDA)</title>
        <description>Percentage of responders were defined as the participants who achieved LDA (DAS28 score &lt; 3.2) at Week 12. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR or CRP value. Total score ranged between 0-10. A DAS28 score greater than 5.1 implies high disease activity, equal to or less than 3.2 low disease activity, and less than 2.6 remissions.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders Achieving Low Disease Activity (LDA)</title>
          <description>Percentage of responders were defined as the participants who achieved LDA (DAS28 score &lt; 3.2) at Week 12. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR or CRP value. Total score ranged between 0-10. A DAS28 score greater than 5.1 implies high disease activity, equal to or less than 3.2 low disease activity, and less than 2.6 remissions.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DAS28 (ESR) LDA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="14.8" upper_limit="56.9"/>
                    <measurement group_id="O2" value="29.4" lower_limit="11.7" upper_limit="53.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAS28 (CRP) LDA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="27.8" upper_limit="72.2"/>
                    <measurement group_id="O2" value="23.5" lower_limit="8.0" upper_limit="47.5"/>
                  </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>DAS28 (ESR) LDA</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>1</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>3.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.7</ci_lower_limit>
            <ci_upper_limit>35.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DAS28 (CRP) LDA</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.1642</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>26.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.6</ci_lower_limit>
            <ci_upper_limit>56.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission</title>
        <description>Participants with disease remission: LDA (DAS28 score&lt; 2.6). The DAS28 index is a composite score of weighted components including both 28 TJC an SJC, participant global assessment of disease activity score, and ESR or CRP value. A DAS28 score greater than 5.1: high disease activity, ≤ 3.2: low disease activity, and less than 2.6: remission. Extended remission criteria included DAS28 &lt; 2.6 and no signs of systemic activity for up to two consecutive study visits till Week 12 defined as any of Yamaguchi´s primary classification criteria for AOSD which included fever attacks at 39 °C for more than a week, arthralgia, salmon red, maculate, urticarial or maculo-papular rash and leukocytosis (white blood cells increase) of &gt; 10000/cubic millimeters (mm^3) with &gt; 80% neutrophils.</description>
        <time_frame>Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission</title>
          <description>Participants with disease remission: LDA (DAS28 score&lt; 2.6). The DAS28 index is a composite score of weighted components including both 28 TJC an SJC, participant global assessment of disease activity score, and ESR or CRP value. A DAS28 score greater than 5.1: high disease activity, ≤ 3.2: low disease activity, and less than 2.6: remission. Extended remission criteria included DAS28 &lt; 2.6 and no signs of systemic activity for up to two consecutive study visits till Week 12 defined as any of Yamaguchi´s primary classification criteria for AOSD which included fever attacks at 39 °C for more than a week, arthralgia, salmon red, maculate, urticarial or maculo-papular rash and leukocytosis (white blood cells increase) of &gt; 10000/cubic millimeters (mm^3) with &gt; 80% neutrophils.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DAS28 (ESR) Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3" lower_limit="14.8" upper_limit="56.9"/>
                    <measurement group_id="O2" value="11.8" lower_limit="2.0" upper_limit="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DAS28 (CRP) Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9" lower_limit="18.9" upper_limit="62.3"/>
                    <measurement group_id="O2" value="11.8" lower_limit="2.0" upper_limit="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extended Remission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="11.0" upper_limit="51.3"/>
                    <measurement group_id="O2" value="11.8" lower_limit="2.0" upper_limit="33.7"/>
                  </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>DAS28 (ESR) remission</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.2285</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>21.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.1</ci_lower_limit>
            <ci_upper_limit>49.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DAS28 (CRP) Remission</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.1212</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>27.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.6</ci_lower_limit>
            <ci_upper_limit>54.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Extended Remission</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Fisher's exact test with a two-tailed level of significance of α = 0.05.</non_inferiority_desc>
            <p_value>0.4018</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference in Response Rates</param_type>
            <param_value>16.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.6</ci_lower_limit>
            <ci_upper_limit>43.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: Change in Joint Mobility (Degrees of Motion) Assessed by Neutral Zero Method</title>
        <description>Number of joints with limitation of motion according to neutral zero method was assessed which included mobility of joints (elbows, wrists, shoulder joints, hip joints, knee joints, and upper ankle joints) within the reference range/degree. Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from Baseline. A negative change score indicates improvement. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: Change in Joint Mobility (Degrees of Motion) Assessed by Neutral Zero Method</title>
          <description>Number of joints with limitation of motion according to neutral zero method was assessed which included mobility of joints (elbows, wrists, shoulder joints, hip joints, knee joints, and upper ankle joints) within the reference range/degree. Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from Baseline. A negative change score indicates improvement. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>degrees</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.94" lower_limit="3.0" upper_limit="6.9"/>
                    <measurement group_id="O2" value="6.29" lower_limit="4.3" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.37" lower_limit="3.4" upper_limit="7.3"/>
                    <measurement group_id="O2" value="6.05" lower_limit="4.0" upper_limit="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score</title>
        <description>The SF-36 determines overall quality of life assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 contribute to physical component summary score (PCS). Items 5-8 contribute to mental component summary score (MCS). Scores on each item are summed and averaged (range = 0 &quot;worst&quot;-100 &quot;best&quot;). Positive numbers indicate improvement from Baseline. LS mean was calculated by MMRM analyses.</description>
        <time_frame>Baseline, Week 12</time_frame>
        <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score</title>
          <description>The SF-36 determines overall quality of life assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 contribute to physical component summary score (PCS). Items 5-8 contribute to mental component summary score (MCS). Scores on each item are summed and averaged (range = 0 &quot;worst&quot;-100 &quot;best&quot;). Positive numbers indicate improvement from Baseline. LS mean was calculated by MMRM analyses.</description>
          <population>ITT population included all participants who did not violate any of the following inclusion criteria: diagnosis of adult-onset Still's disease and disease activity based on DAS28 score of ≥ 3.2 at Screening. Number analyzed is the number of participants with data available for analyses at the given timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SF-36 Physical: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.39" lower_limit="24.5" upper_limit="34.3"/>
                    <measurement group_id="O2" value="28.73" lower_limit="23.7" upper_limit="33.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36 Physical: CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.03" lower_limit="36.0" upper_limit="46.1"/>
                    <measurement group_id="O2" value="33.45" lower_limit="27.9" upper_limit="39.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36 Mental: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.8" lower_limit="32.0" upper_limit="43.6"/>
                    <measurement group_id="O2" value="46.31" lower_limit="40.4" upper_limit="52.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SF-36 Mental: CFB at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.47" lower_limit="37.6" upper_limit="49.3"/>
                    <measurement group_id="O2" value="49.82" lower_limit="43.6" upper_limit="56.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE is an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. AEs include symptoms of illnesses, as well as every unfavourable and unintended reaction. SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.</description>
        <time_frame>Up to Month 27</time_frame>
        <population>Safety Analysis Set included all participants randomized who received at least one dose of the study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Core Study Part I: Canakinumab</title>
            <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O2">
            <title>Core Study Part I: Placebo</title>
            <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
          </group>
          <group group_id="O3">
            <title>Core Study Part II: Canakinumab Responders</title>
            <description>Participants with response (change in DAS score &gt; 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.</description>
          </group>
          <group group_id="O4">
            <title>Core Study Part II: Placebo Responders</title>
            <description>Participants with response (change in DAS score &gt; 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.</description>
          </group>
          <group group_id="O5">
            <title>Core Study Part II: Placebo Non-responders</title>
            <description>Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.</description>
          </group>
          <group group_id="O6">
            <title>LTE Phase: Canakinumab</title>
            <description>Participants with remission (change in DAS score &gt; 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE is an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. AEs include symptoms of illnesses, as well as every unfavourable and unintended reaction. SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.</description>
          <population>Safety Analysis Set included all participants randomized who received at least one dose of the study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Month 27</time_frame>
      <desc>Safety Analysis Set included all participants randomized who received at least one dose of the study drug. 2 participants of the placebo group in Part I received canakinumab at Week 4, as protocol violation, thus, Safety Analysis Set included those additional 2 participants in the canakinumab group.</desc>
      <group_list>
        <group group_id="E1">
          <title>Core Study Part I: Canakinumab</title>
          <description>Participants received canakinumab 4 mg/kg up to 300 mg maximum, subcutaneous (SC) injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
        </group>
        <group group_id="E2">
          <title>Core Study Part I: Placebo</title>
          <description>Participants received placebo, SC injection, once in morning at Baseline (Day 0), Weeks 4, 8, and 12.</description>
        </group>
        <group group_id="E3">
          <title>Core Study Part II: Canakinumab Responders</title>
          <description>Participants with response (change in DAS score &gt; 1.2 at Week 12) continued to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning for Weeks 12, 16, and 20.</description>
        </group>
        <group group_id="E4">
          <title>Core Study Part II: Placebo Responders</title>
          <description>Participants with response (change in DAS score &gt; 1.2 at Week 12) continued to receive placebo, SC injection, once in morning for Weeks 12, 16, and 20.</description>
        </group>
        <group group_id="E5">
          <title>Core Study Part II: Placebo Non-responders</title>
          <description>Placebo Non-responders (change in DAS score ≤ 1.2 at Week 12) who switched to canakinumab were unblinded to receive canakinumab 4 mg/kg up to 300 mg maximum, SC injection, once in the morning at Weeks 12, 16, and 20.</description>
        </group>
        <group group_id="E6">
          <title>LTE Phase: Canakinumab</title>
          <description>Participants with remission (change in DAS score &gt; 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) received canakinumab 4 mg/kg up to 300 mg maximum, SC injection at Weeks 24 and 28, which was down titrated to 2 mg/kg up to 150 mg maximum if applicable after Week 28 up to Month 27 (Week 117).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Chondromalacia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Patellofemoral pain syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Medical device removal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.1)</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="16" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eyelid oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Aphthous ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Injection site rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Primary biliary cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hand-foot-and-mouth disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="3" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pertussis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Appetite disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </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="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pseudarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Still's disease</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Tenosynovitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Anogenital warts</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Intercostal neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Vulva cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </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="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Nail dystrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="7"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study terminated prior to the planned completion date due to recruitment issues because of the marketing authorization of the study drug.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Prof. Dr Eugen Feist</name_or_title>
      <organization>Helios Fachklinik Vogelsang-Gommern GmbH, Germany</organization>
      <phone>+49 30 450 513 192</phone>
      <email>eugen.feist@charite.de</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/NCT02204293
org study id: CACZ885GDE01T
secondary id: 2011-001027-20
nct id: NCT02204293
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this trial is to investigate the efficacy of the treatment with canakinumab in
      participants with Adult-onset Still's Disease (AOSD) and active joint involvement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Core Study Part I: Percentage of Responders as Assessed by Disease Activity Score 28 Joints (DAS28) Score at Week 12
time frame: Week 12
description: Responders included participants with change in disease activity score based on 28 joint counts and ESR (DAS28) score > 1.2. The DAS28 score index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and the erythrocyte sedimentation rate (ESR) value. Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission.
measure: Core Study Part I: Change From Baseline (CFB) in Disease Activity Score 28 Joints Erythrocyte Sedimentation Rate (DAS28 [ESR]) Score
time frame: Baseline, Weeks 4, 8 and 12
description: The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and ESR value.Total score ranged between 0-10. A DAS28-ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. Least squares (LS) mean was calculated by mixed linear model for repeated measures (MMRM) analyses.
measure: Core Study Part I: CFB in DAS28 C-reactive Protein (CRP) Score
time frame: Baseline, Weeks 4, 8 and 12
description: The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, patient global assessment of disease activity score, and CRP value. Total score ranged between 0-10. A DAS28-CRP score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission. A positive change in score indicates worsening, and a negative change indicates improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in American College of Rheumatology (ACR) Component: 68 Tender Joint Count (TJC)
time frame: Baseline, Weeks 4, 8 and 12
description: The 68 TJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 hip, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Joint tenderness was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no tender joint) to 68 (all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in ACR Component: 66 Swollen Joint Count (SJC)
time frame: Baseline, Weeks 4, 8 and 12
description: The 66 SJC included the 8 distal interphalangeal (IP), 10 proximal IP and 10 metacarpophalangeal (MTP) joints of hands, the 10 MTP and 10 proximal IP joints of feet, the 2 wrists, 2 elbows, 2 shoulders, 2 acromioclavicular, 2 sternoclavicular, 2 temporomandibular, 2 knee, 2 talo-tibial, and 2 mid-tarsal joints. Swelling was graded present (1) or absent (0). Total score is calculated by adding the scores, which range from 0 (no swollen joint) to 66 (all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints. A negative change in Baseline indicates improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in the 28 TJC
time frame: Baseline, Weeks 4, 8 and 12
description: A total of 28 joints were assessed for tenderness. The number of tender joints could range from 0 to 28, where higher values represented more tender joints. The change from Baseline to any time points was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in the 28 SJC
time frame: Baseline, Weeks 4, 8 and 12
description: A total of 28 joints were assessed for swelling. The number of swollen joints could range from 0 to 28, where higher values represented more swollen joints. The change from Baseline to any time point was averaged among all participants, where negative changes indicated an improvement in disease activity. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in ACR Component: Acute Phase Reactant CRP
time frame: Baseline, Weeks 4, 8 and 12
description: A negative change from Baseline in CRP level indicates an improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in ACR Component: Acute Phase Reactant ESR
time frame: Baseline, Weeks 4, 8 and 12
description: A negative change from Baseline in ESR level indicates an improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in Serum Ferritin Level at Week 12
time frame: Week 12
description: LS mean was calculated by MMRM analyses.
measure: Core Study Part I: Percentage of Responders With Fever Episodes
time frame: Week 12
description: Fever is defined as an oral or rectal body temperature greater than 38 degrees Celsius (°C).
measure: Core Study Part I: CFB in ACR Component: Physician's Global Assessment of Disease Activity Score
time frame: Baseline, Weeks 4, 8 and 12
description: The physician's global assessment of disease activity was assessed using a numerical rating scale of 0-10 where 0= no disease activity and 10= activity to maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Disease Activity Score
time frame: Baseline, Weeks 4, 8 and 12
description: The participant's global assessment of disease activity was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in ACR Component: Participant's Global Assessment of Pain Score
time frame: Baseline, Weeks 4, 8 and 12
description: The participant's global assessment of pain was assessed using a numerical rating scale of 0-10, where 0= no disease activity and 10= maximal disease activity. A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
time frame: Baseline, Week 12
description: The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from Baseline indicates improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: Percentage of Responders With American College of Rheumatology Response of 20 (ACR20)
time frame: Baseline, Week 12
description: ACR20 response was defined as a ≥ 20% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.
measure: Core Study Part I: Percentage of Responders With ACR30
time frame: Baseline, Week 12
description: ACR30 response was defined as a ≥ 30% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.
measure: Core Study Part I: Percentage of Responders With Modified ACR30
time frame: Baseline, Week 12
description: A participant was considered responder if he/she had achieved the incidence of modified adapted response (ACR30 criteria) of at least a 30% improvement in no intermittent fever and had at least 30% improvement in at least 6 of the following 7 measures: tender and swollen 68-joint counts, participant's assessment of pain, participant's global assessment of disease activity, physician's global assessment of disease activity, participant's functional capacity (HAQ-DI score) and acute phase reactant- ESR. Participant were modified ACR30 responders at a given post-randomization visit if they satisfied the modified ACR30 criteria, respectively.
measure: Core Study Part I: Percentage of Responders With ACR50
time frame: Baseline, Week 12
description: ACR50 response was defined as a ≥ 50% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.
measure: Core Study Part I: Percentage of Responders With ACR70
time frame: Baseline, Week 12
description: ACR70 response was defined as a ≥ 70% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.
measure: Core Study Part I: Percentage of Responders With ACR90
time frame: Baseline, Week 12
description: ACR90 response was defined as a ≥ 90% improvement (reduction) compared with Baseline for both 68 TJC and 66 SJC, as well as for three of the additional five ACR core set variables: Participant's Assessment of Pain over the previous 24 hours: using a NRS left end of the line 0=no pain to right end of the line 10=unbearable pain; Participant's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a NRS where left end of the line 0=no disease activity to right end of the line 10=maximum disease activity; HAQ-DI 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant ESR.
measure: Core Study Part I: Percentage of Responders With European League Against Rheumatism (EULAR) Response
time frame: Baseline, Week 12
description: EULAR response is based on DAS28-ESR and DAS28-CRP scores. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, subject global assessment of disease activity score, and ESR or CRP value. A DAS28-CRP or ESR score of 5.1 or above = high disease activity, a value between 3.2 and 5.1 = moderate disease activity and value between 2.6 and 3.2 = low disease activity, value < 2.6 = disease remission. EULAR response has 3 categories: EULAR Good response: DAS28 ≤ 3.2 and a change from Baseline < -1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a change from Baseline < -0.6 to ≥ -1.2 or EULAR No response: DAS28 >5.1 or a change from Baseline < -0.6 to ≤ -1.2.
measure: Core Study Part I: Percentage of Responders Achieving Low Disease Activity (LDA)
time frame: Week 12
description: Percentage of responders were defined as the participants who achieved LDA (DAS28 score < 3.2) at Week 12. The DAS28 index is a composite score of weighted components including tender joint counts of 28, swollen joint counts of 28, participant global assessment of disease activity score, and ESR or CRP value. Total score ranged between 0-10. A DAS28 score greater than 5.1 implies high disease activity, equal to or less than 3.2 low disease activity, and less than 2.6 remissions.
measure: Core Study Part I: Percentage of Responders Achieving Disease Remission and Extended Disease Remission
time frame: Week 12
description: Participants with disease remission: LDA (DAS28 score< 2.6). The DAS28 index is a composite score of weighted components including both 28 TJC an SJC, participant global assessment of disease activity score, and ESR or CRP value. A DAS28 score greater than 5.1: high disease activity, ≤ 3.2: low disease activity, and less than 2.6: remission. Extended remission criteria included DAS28 < 2.6 and no signs of systemic activity for up to two consecutive study visits till Week 12 defined as any of Yamaguchi´s primary classification criteria for AOSD which included fever attacks at 39 °C for more than a week, arthralgia, salmon red, maculate, urticarial or maculo-papular rash and leukocytosis (white blood cells increase) of > 10000/cubic millimeters (mm^3) with > 80% neutrophils.
measure: Core Study Part I: Change in Joint Mobility (Degrees of Motion) Assessed by Neutral Zero Method
time frame: Baseline, Week 12
description: Number of joints with limitation of motion according to neutral zero method was assessed which included mobility of joints (elbows, wrists, shoulder joints, hip joints, knee joints, and upper ankle joints) within the reference range/degree. Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from Baseline. A negative change score indicates improvement. LS mean was calculated by MMRM analyses.
measure: Core Study Part I: CFB in Medical Outcome Short Form (SF-36) Health Survey Score
time frame: Baseline, Week 12
description: The SF-36 determines overall quality of life assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 contribute to physical component summary score (PCS). Items 5-8 contribute to mental component summary score (MCS). Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Positive numbers indicate improvement from Baseline. LS mean was calculated by MMRM analyses.
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Up to Month 27
description: An AE is an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. AEs include symptoms of illnesses, as well as every unfavourable and unintended reaction. SAEs are AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.
arm group label: Canakinumab
arm group type: Experimental
description: Participants received canakinumab 4 mg/kg up to a maximum of 300 mg subcutaneous (SC) injection, once in morning on Day 0, Weeks 4, 8, and 12 in Part I of the core study. Participants with response (change in DAS score > 1.2 at Week 12) continued to receive same dose of canakinumab in Part II for Weeks 12, 16, and 20. Participants who had remission (change in DAS score > 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) entered Long-term extension (LTE) phase and received same dose of canakinumab at Weeks 24 and 28, which was down titrated to 2 mg/kg if applicable from Week 28 up to Month 27.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo, SC injection, once in morning on Day 0, Weeks 4, 8, and 12 in Part I of the core study. Participants with response (change in DAS score > 1.2 at Week 12) continued to receive placebo at Weeks 12, 16, and 20. Non-responders (who had change in DAS score ≤ 1.2) were unblinded to receive canakinumab 4 mg/kg (up to 300 mg maximum), SC injection, at Weeks 12, 16, and 20. Participants who had remission (change in DAS score > 1.2 and no signs of systemic activity for adult-onset Still's disease at Week 20) entered Long-term extension (LTE) phase and received same dose of canakinumab at Weeks 24 and 28, which was down titrated to 2 mg/kg if applicable from Week 28 up to Month 27.
intervention type: Drug
intervention name: Canakinumab
description: Canakinumab, single-dose 4 mg/kg up to 300 mg administered subcutaneously.
arm group label: Canakinumab
arm group label: Placebo
other name: Ilaris
intervention type: Drug
intervention name: Placebo
description: Matching placebo administered subcutaneously.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Eugen Feist, Prof. Dr.
role: Principal Investigator
affiliation: Charité University Berlin Germany
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
url: http://ard.bmj.com/content/early/2020/05/13/annrheumdis-2020-217155
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Eugen Feist
investigator title: Prof. Dr Eugen Feist
mesh term: Arthritis, Juvenile
mesh term: Still's Disease, Adult-Onset
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study terminated prior to the planned completion date due to recruitment issues because of the marketing authorization of the study drug.
point of contact: 