<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/NCT02207231</url>
  </required_header>
  <id_info>
    <org_study_id>CR105047</org_study_id>
    <secondary_id>CNTO1959PSO3001</secondary_id>
    <secondary_id>2014-000719-15</secondary_id>
    <nct_id>NCT02207231</nct_id>
  </id_info>
  <brief_title>A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis</brief_title>
  <acronym>VOYAGE 1</acronym>
  <official_title>Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects With Moderate to Severe Plaque-type Psoriasis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab&#xD;
      (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized (assignment of study drug by chance), double-blind (neither the&#xD;
      participant or study staff will know the identity of study drugs), placebo- (inactive&#xD;
      substance identical in appearance to study drug) and active-comparator-controlled (use of an&#xD;
      approved drug to compare with study drug) study of guselkumab in participants with moderate&#xD;
      to severe plaque-type psoriasis (scaly skin rash). The active comparator study drug is&#xD;
      adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis.&#xD;
      Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a&#xD;
      2:1:2 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose&#xD;
      regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III&#xD;
      (adalimumab at standard psoriasis dosing). All participants will receive guselkumab every 8&#xD;
      weeks (q8w) from Week 52 through Week 252 (open label treatment period).The end of the study&#xD;
      is defined as the time the last participant completes the Week 264 visit. Participants will&#xD;
      primarily be assessed for Investigator's Global Assessment (IGA) Score of 0 or 1 and&#xD;
      Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. The total duration of the&#xD;
      study will be approximately 268 weeks (includes a 4-week screening period). Participants will&#xD;
      be monitored for safety throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2014</start_date>
  <completion_date type="Actual">June 17, 2020</completion_date>
  <primary_completion_date type="Actual">September 29, 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</measure>
    <time_frame>Week 24 and 48</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</measure>
    <time_frame>Week 24 and 48</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</measure>
    <time_frame>Week 24 and 48</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</measure>
    <time_frame>Baseline, Week 16</time_frame>
    <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group</measure>
    <time_frame>Week 16</time_frame>
    <description>The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</measure>
    <time_frame>Baseline and Week 16</time_frame>
    <description>The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24</measure>
    <time_frame>Week 24</time_frame>
    <description>The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved PASI 90 Response at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved PASI 75 Response at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a DLQI Score of 0 or 1 at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252</measure>
    <time_frame>Week 252</time_frame>
    <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">837</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Guselkumab 100 milligram (mg) at Weeks 0, 4, and 12 and every 8 weeks (q8w) thereafter through Week 252, placebo for guselkumab at Week 16, and placebo for adalimumab (two 0.8 milliliter [mL] injections) at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, and 5, and every 2 weeks (q2w) thereafter through Week 47.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received Placebo for guselkumab at Weeks 0, 4, and 12, and placebo for adalimumab (two 0.8 mL injections) at Week 0, followed by one 0.8 mL injection at Weeks 1, 3, and 5, and q2w through Week 15. At Week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20 and q8w thereafter through Week 252, as well as placebo for adalimumab at Weeks 17, 19, 21, and 23, and q2w thereafter through Week 47.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received Adalimumab 80 mg at Week 0 (two 40 mg [0.8 mL] injections) and 40 mg at Weeks 1, 3, 5, and q2w thereafter through Week 47, placebo for guselkumab at Weeks 0, 4, 12, 16, and 20, and q8w thereafter through Week 44 and guselkumab 100 mg at Weeks 52, 60, and q8w thereafter through Week 252.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Guselkumab 100 mg</intervention_name>
    <description>100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
    <other_name>CNTO 1959</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for guselkumab</intervention_name>
    <description>Subcutaneous injections to maintain the blind.</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adalimumab</intervention_name>
    <description>80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.</description>
    <arm_group_label>Group III</arm_group_label>
    <other_name>HUMIRA®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for adalimumab</intervention_name>
    <description>Subcutaneous injections to maintain the blind.</description>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of plaque-type psoriasis (with or without psoriatic arthritis) at&#xD;
             least 6 months before the first administration of study agent&#xD;
&#xD;
          -  Have a Psoriasis Area and Severity Index (PASI) greater than or equal to (&gt;=) 12 at&#xD;
             Screening and at Baseline&#xD;
&#xD;
          -  Have an Investigator's Global Assessment (IGA) score &gt;=3 at Screening and at Baseline&#xD;
&#xD;
          -  Have an involved body surface area (BSA) &gt;=10 percent (%) at Screening and at Baseline&#xD;
&#xD;
          -  Must be a candidate for either systemic therapy or phototherapy for psoriasis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with nonplaque forms of psoriasis (for example, erythrodermic, guttate,&#xD;
             or pustular) or with current drug-induced psoriasis (for example, a new onset of&#xD;
             psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel&#xD;
             blockers, or lithium)&#xD;
&#xD;
          -  Participants who have ever received guselkumab or adalimumab&#xD;
&#xD;
          -  History or current signs or symptoms of severe, progressive, or uncontrolled renal,&#xD;
             hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic,&#xD;
             hematologic, rheumatologic, psychiatric, or metabolic disturbances&#xD;
&#xD;
          -  Has any condition that, in the opinion of the investigator, would make participation&#xD;
             not be in the best interest (for example, compromise the well-being) of the&#xD;
             participant or that could prevent, limit, or confound the protocol-specified&#xD;
             assessments&#xD;
&#xD;
          -  Is pregnant, nursing, or planning a pregnancy (both men and women) within 5 months&#xD;
             following the last administration of study drug&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Farmington</city>
        <state>Connecticut</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Alpharetta</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rolling Meadows</city>
        <state>Illinois</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>New Brighton</city>
        <state>Minnesota</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>East Windsor</city>
        <state>New Jersey</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Johnston</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Arlington</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Webster</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Darlinghurst</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>East Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hectorville</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Liverpool</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Westmead</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woden</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Woolloongabba</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. John's</city>
        <state>Newfoundland and Labrador</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>North Bay</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Peterborough</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bonn</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dresden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Frankfurt/ Main</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gera</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lubeck</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mahlow</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Munster</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tübingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Debrecen</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaposvar</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kecskemet</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pecs</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bundang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bialystok</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bydgoszcz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olsztyn</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wroclaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ekaterinburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kirov</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krasnodar</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lipetsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rostov-on-Don</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ryazan</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Petersburg</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Stavropol</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ulyanovsk</city>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Baracaldo</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cordoba</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Manises</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Palma de Mallorca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salamanca</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Sebastian de los Reyes</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaohsiung</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taichung City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tainan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei City</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Taoyuan</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <results_first_submitted>July 25, 2017</results_first_submitted>
  <results_first_submitted_qc>September 15, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2017</results_first_posted>
  <disposition_first_submitted>June 13, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>June 13, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">June 15, 2016</disposition_first_posted>
  <last_update_submitted>July 22, 2021</last_update_submitted>
  <last_update_submitted_qc>July 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Psoriasis</keyword>
  <keyword>Plaque-type psoriasis</keyword>
  <keyword>Guselkumab</keyword>
  <keyword>Adalimumab</keyword>
  <keyword>CNTO 1959</keyword>
  <keyword>Monoclonal antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Then Guselkumab 100 mg</title>
          <description>Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.</description>
        </group>
        <group group_id="P2">
          <title>Guselkumab 100 mg</title>
          <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.</description>
        </group>
        <group group_id="P3">
          <title>Adalimumab Then Guselkumab 100 mg</title>
          <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
        </group>
        <group group_id="P4">
          <title>Guselkumab Combined</title>
          <description>All participants who received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Placebo Controlled Period: Week 0 - 16</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="329"/>
                <participants group_id="P3" count="334"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="174"/>
                <participants group_id="P2" count="329"/>
                <participants group_id="P3" count="333"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="167"/>
                <participants group_id="P2" count="322"/>
                <participants group_id="P3" count="324"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Active Controlled Period: Week 16 - 48</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="165">2 participants did not cross-over.</participants>
                <participants group_id="P2" count="322"/>
                <participants group_id="P3" count="324"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="301"/>
                <participants group_id="P3" count="281"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Open-label Guselkumab: Week 48 - 264</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="280">One participant did not crossover at Week 52 due to adverse event.</participants>
                <participants group_id="P4" count="463">162 + 301= 463</participants>
              </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="242"/>
                <participants group_id="P4" count="380"/>
              </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="38"/>
                <participants group_id="P4" count="83"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="28"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Randomized analysis set included all participants who were randomized at Week 0.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo Then Guselkumab 100 mg</title>
          <description>Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP). Participants then crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 and placebo matched to adalimumab subcutaneous injection at Weeks 17, 19, 21, and 23 and every 2 weeks thereafter through Week 47 in the active controlled period (ACP). Participants continued to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open-label treatment period.</description>
        </group>
        <group group_id="B2">
          <title>Guselkumab 100 mg</title>
          <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47. Participants receiving guselkumab continued to receive guselkumab 100mg subcutaneously q8w at Week 52 and thereafter through Week 252 in the open label period.</description>
        </group>
        <group group_id="B3">
          <title>Adalimumab Then Guselkumab 100 mg</title>
          <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
        </group>
        <group group_id="B4">
          <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="174"/>
            <count group_id="B2" value="329"/>
            <count group_id="B3" value="334"/>
            <count group_id="B4" value="837"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                    <measurement group_id="B2" value="311"/>
                    <measurement group_id="B3" value="315"/>
                    <measurement group_id="B4" value="790"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.9" spread="12.9"/>
                    <measurement group_id="B2" value="43.9" spread="12.74"/>
                    <measurement group_id="B3" value="42.9" spread="12.58"/>
                    <measurement group_id="B4" value="43.7" spread="12.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="229"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="119"/>
                    <measurement group_id="B2" value="240"/>
                    <measurement group_id="B3" value="249"/>
                    <measurement group_id="B4" value="608"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan, Province Of China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hungary</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="49"/>
                    <measurement group_id="B4" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="48"/>
                    <measurement group_id="B4" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="67"/>
                    <measurement group_id="B4" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="43"/>
                    <measurement group_id="B4" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Korea, Democratic People'S Republic Of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="174"/>
                <count group_id="O2" value="329"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9"/>
                    <measurement group_id="O2" value="85.1"/>
                  </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 or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
          <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="174"/>
                <count group_id="O2" value="329"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                    <measurement group_id="O2" value="73.3"/>
                  </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>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 24 and 48</time_frame>
        <population>Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.</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="329"/>
                <count group_id="O2" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.6"/>
                    <measurement group_id="O2" value="29.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.5"/>
                    <measurement group_id="O2" value="25.7"/>
                  </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>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 24 and 48</time_frame>
        <population>Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.</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="329"/>
                <count group_id="O2" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.2"/>
                    <measurement group_id="O2" value="61.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.5"/>
                    <measurement group_id="O2" value="55.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 24 and 48</time_frame>
        <population>Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
          <population>Randomized analysis set included all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 24 or Week 48 or who did not come for evaluation at Week 24 or Week 48 were considered nonresponders, respectively, for Week 24 or Week 48 outcome measures) was used to impute missing values.</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="329"/>
                <count group_id="O2" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.2"/>
                    <measurement group_id="O2" value="53.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 48</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.3"/>
                    <measurement group_id="O2" value="47.9"/>
                  </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>
            <groups_desc>Week 24</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Week 48</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
        <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
        <time_frame>Baseline, Week 16</time_frame>
        <population>Randomized analysis set included all participants who were randomized at Week 0 and have a baseline DLQI score.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
          <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
          <population>Randomized analysis set included all participants who were randomized at Week 0 and have a baseline DLQI score.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="174"/>
                <count group_id="O2" value="329"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.6" spread="6.36"/>
                    <measurement group_id="O2" value="-11.2" spread="7.24"/>
                  </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>p value is based on analysis of variance (ANOVA) model stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).</description>
          <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="329"/>
                <count group_id="O2" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.1"/>
                    <measurement group_id="O2" value="65.9"/>
                  </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>
            <groups_desc>p value is based on 1-sided Mantel Haenszel (MH) Z-test adjusted for investigator site (pooled).</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>non-inferiority margin= 10.0%</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>MH Z-test</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>19.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.9</ci_lower_limit>
            <ci_upper_limit>25.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.</description>
          <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="329"/>
                <count group_id="O2" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3"/>
                    <measurement group_id="O2" value="49.7"/>
                  </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>p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>non-inferiority margin= 10.0%</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>MH Z-test</method>
            <param_type>Difference in Percentage</param_type>
            <param_value>24.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.0</ci_lower_limit>
            <ci_upper_limit>31.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.</description>
        <time_frame>Week 16</time_frame>
        <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 15 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.</description>
          <population>Randomized analysis set include all participants randomized at Week 0. Nonresponder imputation (participants who met treatment-failure criteria before Week 16 or who did not come for evaluation at week 16 were considered nonresponders) was used to impute missing values.</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="329"/>
                <count group_id="O2" value="334"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.2"/>
                    <measurement group_id="O2" value="73.1"/>
                  </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>p value is based on 1-sided MH Z-test adjusted for investigator site (pooled).</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence (legacy)</non_inferiority_type>
            <non_inferiority_desc>non-inferiority margin= 10%</non_inferiority_desc>
            <p_value>&lt; 0.001</p_value>
            <method>MH Z-test</method>
            <param_type>Difference in percentage</param_type>
            <param_value>18.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.4</ci_lower_limit>
            <ci_upper_limit>23.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
        <description>The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
        <time_frame>Week 16</time_frame>
        <population>Population analyzed included only randomized participants at Week 0 who had an ss-IGA score greater than or equal to (&gt;=) 2 at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
          <description>The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
          <population>Population analyzed included only randomized participants at Week 0 who had an ss-IGA score greater than or equal to (&gt;=) 2 at baseline.</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="145"/>
                <count group_id="O2" value="277"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5"/>
                    <measurement group_id="O2" value="83.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
        <description>The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
        <time_frame>Baseline and Week 16</time_frame>
        <population>PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0, followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and once every 2 weeks thereafter through Week 15 in the placebo controlled period (PCP).</description>
          </group>
          <group group_id="O2">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 15.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group</title>
          <description>The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.</description>
          <population>PSSD analysis set included all those participants who had baseline PSSD scores as the average score of at least 4 days out of the 7 days prior to the Week 0 visit.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="129"/>
                <count group_id="O2" value="249"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="19.56"/>
                    <measurement group_id="O2" value="-41.9" spread="24.61"/>
                  </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>p value is based on ANOVA model stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
        <description>The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
        <time_frame>Week 24</time_frame>
        <population>PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab</title>
            <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24</title>
          <description>The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.</description>
          <population>PSSD analysis set included all those participants who were randomized at Week 0 and had baseline PSSD score greater than 0.</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="248"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.3"/>
                    <measurement group_id="O2" value="21.6"/>
                  </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>p value is based on the Cochran-Mantel-Haenszel chi-square test stratified by investigator site (pooled).</groups_desc>
            <non_inferiority_type>Superiority or Other (legacy)</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Cochran-Mantel-Haenszel chi-square test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved PASI 90 Response at Week 252</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved PASI 90 Response at Week 252</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="391"/>
                <count group_id="O2" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.1"/>
                    <measurement group_id="O2" value="82.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved PASI 75 Response at Week 252</title>
        <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved PASI 75 Response at Week 252</title>
          <description>The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="391"/>
                <count group_id="O2" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.9"/>
                    <measurement group_id="O2" value="93.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252</title>
        <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252</title>
          <description>The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="391"/>
                <count group_id="O2" value="246"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4"/>
                    <measurement group_id="O2" value="82.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 252</title>
        <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline DLQI score &gt;1. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a DLQI Score of 0 or 1 at Week 252</title>
          <description>The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline DLQI score &gt;1. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="374"/>
                <count group_id="O2" value="235"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.7"/>
                    <measurement group_id="O2" value="74.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252</title>
        <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD symptom score &gt;0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252</title>
          <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD symptom score &gt;0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="297"/>
                <count group_id="O2" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.4"/>
                    <measurement group_id="O2" value="48.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252</title>
        <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
        <time_frame>Week 252</time_frame>
        <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD sign score &gt;0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Guselkumab Combined</title>
            <description>All participants who crossed over to receive guselkumab 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab.</description>
          </group>
          <group group_id="O2">
            <title>Adalimumab Then Guselkumab 100 mg</title>
            <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44. Participants entered a washout period after their final dose of adalimumab at Week 47 and received guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252</title>
          <description>The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (&gt;=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.</description>
          <population>Population analyzed included participants who were randomized at Week 0 and treated with guselkumab with baseline PSSD sign score &gt;0. The analysis was performed using observed data after applying treatment failure rules. Here, N (Number of participants analyzed) signifies participants who were analyzed for this outcome measure.</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="297"/>
                <count group_id="O2" value="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.0"/>
                    <measurement group_id="O2" value="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline (Week 0) up to Week 264</time_frame>
      <desc>Safety analysis- participants who were randomized at Week 0, received at least 1 dose of study drug (partial/complete). Participants who discontinued treatment prematurely were followed for at least 12 weeks after last dose. Participants who discontinued in 1st period and had safety follow-up beyond Week 16, counted in both periods for safety. Discrepancy in number of participants in participant flow and numbers at risk in adverse events for GUS combined arm is justified in GUS arm description.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (PCP)</title>
          <description>Participants received placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.</description>
        </group>
        <group group_id="E2">
          <title>Guselkumab 100 mg (PCP)</title>
          <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 during the placebo controlled period.</description>
        </group>
        <group group_id="E3">
          <title>Adalimumab (PCP)</title>
          <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Week 1 and once every other week thereafter through Week 15 during the placebo controlled period.</description>
        </group>
        <group group_id="E4">
          <title>Placebo Then Guselkumab 100 mg (ACP)</title>
          <description>Participants initially randomized to placebo crossed over to receive guselkumab 100 milligram (mg) subcutaneous injection at Weeks 16 and 20 and once every 8 weeks thereafter through Week 44 in the active controlled period (ACP).</description>
        </group>
        <group group_id="E5">
          <title>Guselkumab 100 mg (ACP)</title>
          <description>Participants received guselkumab 100 mg subcutaneous injection at Weeks 0, 4, and 12 and once every 8 weeks thereafter through Week 44, placebo matched to guselkumab subcutaneous injection at Week 16, and placebo matched to adalimumab (2 subcutaneous injections) at Week 0 followed by placebo matched to adalimumab (1 subcutaneous injection) at Weeks 1, 3, and 5 and every 2 weeks thereafter through Week 47.</description>
        </group>
        <group group_id="E6">
          <title>Adalimumab (ACP)</title>
          <description>Participants received adalimumab 80 mg (2 subcutaneous injections) at Week 0 and adalimumab 40 mg (1 subcutaneous injection) at Weeks 1, 3, 5 and once every 2 weeks thereafter through Week 47 and placebo matched to guselkumab subcutaneous injection at Weeks 0, 4, 12, 16, 20 and once every 8 weeks thereafter through Week 44.</description>
        </group>
        <group group_id="E7">
          <title>Adalimumab Then Guselkumab 100 mg (After ACP)</title>
          <description>Participants initially randomized to adalimumab entered a washout period after their final dose at Week 47 and crossed over to receive guselkumab 100 mg subcutaneously q8w at Week 52 and thereafter through Week 252. This arm reports safety data for participants that crossed over to guselkumab from adalimumab.</description>
        </group>
        <group group_id="E8">
          <title>Guselkumab Combined</title>
          <description>All participants who crossed over to receive guselkumab (GUS) 100 mg subcutaneously at Week 16 from placebo group and participants who were randomized to guselkumab 100 mg group at Week 0. Placebo crossover participants were included in the guselkumab column after crossover to guselkumab. Participants that discontinued treatment prematurely were followed up for safety and hence were included in the safety data. Therefore, combined safety results are reported for this arm. This arm reports safety data for guselkumab.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="34" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="79" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Aortic Valve Incompetence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Myocardial Ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Sinus Node Dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Dermoid Cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Duodenal Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Enterocutaneous Fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Intestinal Strangulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Large Intestine Polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Umbilical Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Hepatic Failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Ischaemic Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Abscess Limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Anal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Chronic Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Ovarian Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Pneumonia Staphylococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Scrotal Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Varicella</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Avulsion Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Cervical Vertebral Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Chest Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Clavicle Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Craniocerebral Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Foreign Body</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Humerus Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Jaw Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Joint Dislocation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Ligament Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Limb Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Meniscus Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Multiple Injuries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Post Procedural Fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Procedural Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Radius Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Skin Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Soft Tissue Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Spinal Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Tendon Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Thoracic Vertebral Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Human Chorionic Gonadotropin Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Chondromalacia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Dupuytren's Contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Lateral Patellar Compression Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Meniscal Degeneration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Metatarsalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Rotator Cuff Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Synovitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Trigger Finger</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Astrocytoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>B-Cell Lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Bladder Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Epiglottic Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Gastric Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Invasive Papillary Breast Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Laryngeal Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Lipoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma in Situ</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Papillary Cystadenoma Lymphomatosum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Rectal Adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Sarcoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Uterine Leiomyoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Balance Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Carpal Tunnel Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Idiopathic Partial Epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Lacunar Infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion Missed</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Abortion Spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Completed Suicide</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Psychotic Disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Substance Abuse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Suicidal Ideation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Suicide Attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Ovarian Cyst Ruptured</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Uterine Polyp</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="2" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Pulmonary Oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Pulmonary Sarcoidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Atopic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Erythema Nodosum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Erythrodermic Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Lichen Planus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Hypertensive Crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Peripheral Artery Stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis Superficial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA Version 23.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="101" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="98" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="67" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="134" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="137" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="193" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="307" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="8" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="13" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="28" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="11" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="5" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="4" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="19" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="23" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="4" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="14" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="25" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="2" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="16" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="20" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="36" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="34" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="65" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="57" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="89" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="148" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="7" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="17" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="18" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="14" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="19" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="31" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="33" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="69" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="107" subjects_at_risk="494"/>
              </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="3" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="26" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="37" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="12" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="22" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="28" subjects_at_risk="494"/>
              </event>
              <event>
                <sub_title>Psoriatic Arthropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="14" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="12" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="7" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="16" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="17" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="28" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="10" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="8" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="20" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="24" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="6" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="7" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="16" subjects_at_risk="494"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="174"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="329"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="333"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="165"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="324"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="326"/>
                <counts group_id="E7" subjects_affected="17" subjects_at_risk="280"/>
                <counts group_id="E8" subjects_affected="40" subjects_at_risk="494"/>
              </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>A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>All participants were on guselkumab after Week 48; therefore, there was no concurrent control group within the study after Week 48.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Senior Director</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02207231
org study id: CR105047
secondary id: CNTO1959PSO3001
secondary id: 2014-000719-15
nct id: NCT02207231
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab
      (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.
This is a randomized (assignment of study drug by chance), double-blind (neither the
      participant or study staff will know the identity of study drugs), placebo- (inactive
      substance identical in appearance to study drug) and active-comparator-controlled (use of an
      approved drug to compare with study drug) study of guselkumab in participants with moderate
      to severe plaque-type psoriasis (scaly skin rash). The active comparator study drug is
      adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis.
      Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a
      2:1:2 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose
      regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III
      (adalimumab at standard psoriasis dosing). All participants will receive guselkumab every 8
      weeks (q8w) from Week 52 through Week 252 (open label treatment period).The end of the study
      is defined as the time the last participant completes the Week 264 visit. Participants will
      primarily be assessed for Investigator's Global Assessment (IGA) Score of 0 or 1 and
      Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. The total duration of the
      study will be approximately 268 weeks (includes a 4-week screening period). Participants will
      be monitored for safety throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Placebo Group at Week 16
time frame: Week 16
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Placebo Group at Week 16
time frame: Week 16
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
time frame: Week 24 and 48
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
time frame: Week 24 and 48
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 24 and 48
time frame: Week 24 and 48
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
time frame: Baseline, Week 16
description: The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
measure: Percentage of Participants Who Achieved an Investigator's Global Assessment (IGA) Score of Cleared (0) or Minimal (1) in the Guselkumab Group Compared to the Adalimumab Group at Week 16
time frame: Week 16
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 90 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
time frame: Week 16
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score.
measure: Percentage of Participants Who Achieved Psoriasis Area and Severity Index (PASI) 75 Response in the Guselkumab Group Compared to the Adalimumab Group at Week 16
time frame: Week 16
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score.
measure: Percentage of Participants Who Achieved a Scalp-specific Investigator's Global Assessment (Ss-IGA) Score of 0 or 1 and at Least a 2-Grade Improvement From Baseline at Week 16 in the Guselkumab Group Compared to the Placebo Group
time frame: Week 16
description: The ss-IGA instrument is used to evaluate the disease severity of scalp psoriasis. The lesions were assessed in terms of the clinical signs of redness, thickness, and scaliness, which are scored on a 5-point scale ranging from 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, and 4 = severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
measure: Change From Baseline in Psoriasis Symptom and Sign Diary (PSSD) Symptom Score at Week 16 in the Guselkumab Group Compared to the Placebo Group
time frame: Baseline and Week 16
description: The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. This secondary outcome measure was planned to include only the placebo and guselkumab arms.
measure: Percentage of Participants Who Achieved a Psoriasis Symptom and Sign Diary (PSSD) Symptom Score of 0 in the Guselkumab Group Compared to the Adalimumab Group at Week 24
time frame: Week 24
description: The PSSD (24-hour version) is a patient-reported outcome (PRO) questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom [or Sign] score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease.
measure: Percentage of Participants Who Achieved PASI 90 Response at Week 252
time frame: Week 252
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants Who Achieved PASI 75 Response at Week 252
time frame: Week 252
description: The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants Who Achieved an IGA Score of Cleared (0) or Minimal (1) at Week 252
time frame: Week 252
description: The IGA documents the investigator's assessment of the participants' psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling. The participants' psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants With a DLQI Score of 0 or 1 at Week 252
time frame: Week 252
description: The DLQI is a 10-item questionnaire that measures the impact of skin disease on participant's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participant's life; 2-6 = small effect on the participant's life; 7-12 = moderate effect on the participant's life; 13-18 = very large effect on the participant's life; 19-30 = extremely large effect on the participant's life. Higher scores indicate more impact on quality of life of participants. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants Who Achieved a PSSD Symptom Score of 0 at Week 252
time frame: Week 252
description: The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Symptom score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
measure: Percentage of Participants Who Achieved a PSSD Sign Score of 0 at Week 252
time frame: Week 252
description: The PSSD (24-hour version) is a PRO questionnaire designed and validated to measure the severity of psoriasis symptoms and signs for the assessment of treatment benefit. It consisted of 11 items covering symptoms (itch, pain, stinging, burning, and skin tightness) and patient-observable signs (skin dryness, cracking, scaling, shedding or flaking, redness, and bleeding) using 0 (absent) to 10 (worst imaginable) numerical rating scales for severity. Items were averaged on the daily symptom score and sign score when at least 3 items (>=50 percentage of 5 items) on these scales are answered. The average value is converted into 0-100 scoring, such that Sign score = average value*10, where, 0= least severe and 100= most severe and higher score indicates more severe disease. As per planned analysis, participants from the baseline guselkumab group and the placebo crossover group were combined into a single guselkumab group for assessment of this outcome measure.
arm group label: Group I
arm group type: Experimental
description: Participants received Guselkumab 100 milligram (mg) at Weeks 0, 4, and 12 and every 8 weeks (q8w) thereafter through Week 252, placebo for guselkumab at Week 16, and placebo for adalimumab (two 0.8 milliliter [mL] injections) at Week 0 followed by one 0.8 mL injection at Weeks 1, 3, and 5, and every 2 weeks (q2w) thereafter through Week 47.
arm group label: Group II
arm group type: Placebo Comparator
description: Participants received Placebo for guselkumab at Weeks 0, 4, and 12, and placebo for adalimumab (two 0.8 mL injections) at Week 0, followed by one 0.8 mL injection at Weeks 1, 3, and 5, and q2w through Week 15. At Week 16, placebo participants will cross over to receive guselkumab 100 mg at Weeks 16 and 20 and q8w thereafter through Week 252, as well as placebo for adalimumab at Weeks 17, 19, 21, and 23, and q2w thereafter through Week 47.
arm group label: Group III
arm group type: Active Comparator
description: Participants received Adalimumab 80 mg at Week 0 (two 40 mg [0.8 mL] injections) and 40 mg at Weeks 1, 3, 5, and q2w thereafter through Week 47, placebo for guselkumab at Weeks 0, 4, 12, 16, and 20, and q8w thereafter through Week 44 and guselkumab 100 mg at Weeks 52, 60, and q8w thereafter through Week 252.
intervention type: Drug
intervention name: Guselkumab 100 mg
description: 100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).
arm group label: Group I
arm group label: Group II
arm group label: Group III
other name: CNTO 1959
intervention type: Drug
intervention name: Placebo for guselkumab
description: Subcutaneous injections to maintain the blind.
arm group label: Group I
arm group label: Group II
arm group label: Group III
intervention type: Drug
intervention name: Adalimumab
description: 80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.
arm group label: Group III
other name: HUMIRA®
intervention type: Drug
intervention name: Placebo for adalimumab
description: Subcutaneous injections to maintain the blind.
arm group label: Group I
arm group label: Group II
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Australia
country: Canada
country: Germany
country: Hungary
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Adalimumab
mesh term: Antibodies, Monoclonal
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reported events: 
certain agreements: 
limitations and caveats: All participants were on guselkumab after Week 48; therefore, there was no concurrent control group within the study after Week 48.
point of contact: 