<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/NCT03304379</url>
  </required_header>
  <id_info>
    <org_study_id>R475-OA-1688</org_study_id>
    <secondary_id>2017-001702-15</secondary_id>
    <nct_id>NCT03304379</nct_id>
  </id_info>
  <brief_title>Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip</brief_title>
  <acronym>FACT OA2</acronym>
  <official_title>Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Regeneron Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Teva Pharmaceutical Industries, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Regeneron Pharmaceuticals</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 primary objective of the study is to evaluate the efficacy of fasinumab compared to&#xD;
      placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis&#xD;
      (OA) of the knee or hip.&#xD;
&#xD;
      The secondary objectives of the study are:&#xD;
&#xD;
        -  To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs&#xD;
           (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the&#xD;
           knee or hip&#xD;
&#xD;
        -  To assess the safety and tolerability of fasinumab compared to placebo and compared to&#xD;
           NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee&#xD;
           or hip&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 26, 2017</start_date>
  <completion_date type="Actual">November 9, 2020</completion_date>
  <primary_completion_date type="Actual">December 13, 2019</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adjudicated Arthropathy (AA) Events</measure>
    <time_frame>Baseline up to follow-up period (Week 44)</time_frame>
    <description>AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria</measure>
    <time_frame>Baseline up to follow-up period (Week 44)</time_frame>
    <description>DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Baseline up to follow-up period (Week 44)</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as an AE with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events</measure>
    <time_frame>Baseline up to follow-up period (Week 44)</time_frame>
    <description>Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)</measure>
    <time_frame>Baseline up to Week 44</time_frame>
    <description>Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24</measure>
    <time_frame>Baseline up to Week 24</time_frame>
    <description>Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44</measure>
    <time_frame>Baseline up to Week 44</time_frame>
    <description>Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)</measure>
    <time_frame>At Week 72</time_frame>
    <description>An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Concentrations of Functional Fasinumab</measure>
    <time_frame>At Weeks 0, 4, 8, 16, 24 and 44</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development</measure>
    <time_frame>Baseline up to Week 44</time_frame>
    <description>Immunogenicity was characterized by ADA responses &amp; titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses &lt; 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, &gt;= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1650</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Osteoarthritis, Hip</condition>
  <arm_group>
    <arm_group_label>Dosing regimen 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dosing regimen 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dosing regimen 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dosing regimen 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fasinumab</intervention_name>
    <description>Solution for injection in pre-filled syringe</description>
    <arm_group_label>Dosing regimen 1</arm_group_label>
    <other_name>REGN475</other_name>
    <other_name>MT-5547</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diclofenac</intervention_name>
    <description>NSAID active comparator (capsule)</description>
    <arm_group_label>Dosing regimen 2</arm_group_label>
    <other_name>ZORVOLEX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Celecoxib</intervention_name>
    <description>NSAID active comparator (capsule)</description>
    <arm_group_label>Dosing regimen 3</arm_group_label>
    <other_name>CELEBREX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Matching placebo</intervention_name>
    <description>Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)</description>
    <arm_group_label>Dosing regimen 1</arm_group_label>
    <arm_group_label>Dosing regimen 2</arm_group_label>
    <arm_group_label>Dosing regimen 3</arm_group_label>
    <arm_group_label>Dosing regimen 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria (additional criteria may apply at screening):&#xD;
&#xD;
          1. A clinical diagnosis of osteoarthritis (OA) of the knee or hip based on the American&#xD;
             College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the&#xD;
             index joint) at the screening visit.&#xD;
&#xD;
          2. Willing to discontinue current pain medications and to adhere to study requirements&#xD;
             for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum&#xD;
             daily dose of 2500 mg [countries where 500 mg strength tablets/capsules are available]&#xD;
             or 2600 mg [countries where 325 mg strength tablets/capsules are available])&#xD;
&#xD;
          3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics&#xD;
             used for pain due to OA of the knee or hip&#xD;
&#xD;
          4. Currently using a stable dose of NSAID&#xD;
&#xD;
          5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during&#xD;
             the 24 weeks of treatment&#xD;
&#xD;
        Key Exclusion Criteria (additional criteria may apply at screening):&#xD;
&#xD;
          1. Non-compliance with the numeric rating scale (NRS) recording during the&#xD;
             pre-randomization period&#xD;
&#xD;
          2. History or presence at the screening visit of non-OA inflammatory joint disease,&#xD;
             Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple&#xD;
             sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal&#xD;
             osteodystrophy&#xD;
&#xD;
          3. History or presence on imaging of arthropathy, hip or knee dislocation, extensive&#xD;
             subchondral cysts, evidence of severe structural damage, bone collapse, or primary&#xD;
             metastatic tumor with the exception of chondromas or pathologic fractures&#xD;
&#xD;
          4. Trauma to the index joint within 3 months prior to the screening visit&#xD;
&#xD;
          5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening&#xD;
&#xD;
          6. Patient is not a candidate for magnetic resonance imaging (MRI)&#xD;
&#xD;
          7. Is scheduled for a JR surgery to be performed during the study period or who would be&#xD;
             unwilling or unable to undergo JR surgery if needed&#xD;
&#xD;
          8. History or presence at the screening visit of autonomic or diabetic neuropathy, or&#xD;
             other peripheral neuropathy, including reflex sympathetic dystrophy&#xD;
&#xD;
          9. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)&#xD;
&#xD;
         10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic&#xD;
             failure, multiple system atrophy&#xD;
&#xD;
         11. Use of systemic corticosteroids within 30 days prior to the screening visit.&#xD;
             Intra-articular corticosteroids in the index joint within 12 weeks prior to the&#xD;
             screening visit, or to any other joint within 30 days prior to the screening visit&#xD;
&#xD;
         12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or&#xD;
             intolerance to anti-NGF antibodies&#xD;
&#xD;
         13. Women of childbearing potential who are unwilling to practice highly effective&#xD;
             contraception prior to the start of the first treatment, during the study, and for at&#xD;
             least 20 weeks after the last dose&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trial Management</last_name>
    <role>Study Director</role>
    <affiliation>Regeneron Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pinnacle Research Group, Llc</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Horizon Research Partners</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Advantage, Inc./Warner Family Practice, PC</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Central Phoenix Medical Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Consortium Arizona</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Research Center</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriWest Research Associates, LLC</name>
      <address>
        <city>El Cajon</city>
        <state>California</state>
        <zip>92020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paragon Rx Clinical Research, Inc.</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catalina Research Institute, LLC</name>
      <address>
        <city>Montclair</city>
        <state>California</state>
        <zip>91763</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sierra Clinical Research</name>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <zip>95661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Center for Musculoskeletal Health</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Center, Inc</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Research Foundation</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paragon Rx Clinical Research, Inc</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encompass Clinical Research</name>
      <address>
        <city>Spring Valley</city>
        <state>California</state>
        <zip>91978</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westlake Medical Research</name>
      <address>
        <city>Thousand Oaks</city>
        <state>California</state>
        <zip>91360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92083</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain View Clinical Research</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New England Research Associates, LLC</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRM of Greater New Haven, LLC</name>
      <address>
        <city>Hamden</city>
        <state>Connecticut</state>
        <zip>06157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stamford Therapeutics Consortium</name>
      <address>
        <city>Stamford</city>
        <state>Connecticut</state>
        <zip>06905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avail Clinical Research, LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakes Research, LLC</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AMB Research Center, Inc</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allied Biomedical Research Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioclinica Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gulf Region Clinical Research institute</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integral Rheumatology &amp; Immunology Specialists (IRIS)</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Studies America</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Georgia Institute For Clinical Research LLC</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Georgia Clinical Research</name>
      <address>
        <city>Woodstock</city>
        <state>Georgia</state>
        <zip>30189</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chicago Clinical Research Institute, Inc</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affinity Clinical Research Institute</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Advantage, Inc.</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediSphere Medical Research Center, LLC</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L-MARC Research Center</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tandem Clinical Research</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center, Inc.</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Research Group, Inc.</name>
      <address>
        <city>Bay City</city>
        <state>Michigan</state>
        <zip>48706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onyx Clinical Research</name>
      <address>
        <city>Caro</city>
        <state>Michigan</state>
        <zip>48723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus Clinical Research US, Inc.</name>
      <address>
        <city>Richfield</city>
        <state>Minnesota</state>
        <zip>55423</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skyline Medical Center /Radiant Research, Inc.</name>
      <address>
        <city>Elkhorn</city>
        <state>Nebraska</state>
        <zip>68022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research Associates, LLC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Kaplan, D.O.</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amici Clinical Research, LLC</name>
      <address>
        <city>Raritan</city>
        <state>New Jersey</state>
        <zip>08869</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albuquerque Clinical Trials, Inc.</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Trial Brooklyn</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drug Trials America</name>
      <address>
        <city>Hartsdale</city>
        <state>New York</state>
        <zip>10530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upstate Clinical Research Associates, LLC</name>
      <address>
        <city>Williamsville</city>
        <state>New York</state>
        <zip>14221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolina Research Center</name>
      <address>
        <city>Shelby</city>
        <state>North Carolina</state>
        <zip>28150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Wilmington LLC</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center For Clinical Research</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizons Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aventiv Research Inc</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DOC Clinical Research</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Orthopaedics and Sports Medicine</name>
      <address>
        <city>Indiana</city>
        <state>Pennsylvania</state>
        <zip>15701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Anderson</city>
        <state>South Carolina</state>
        <zip>29621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Comprehensive Pain Management Group</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiant Research, Inc.</name>
      <address>
        <city>Greer</city>
        <state>South Carolina</state>
        <zip>29651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Research Partners, LLC</name>
      <address>
        <city>Indian Land</city>
        <state>South Carolina</state>
        <zip>29707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Carolina Research Center at LowCountry Orthopaedics</name>
      <address>
        <city>North Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ACME Research, LLC</name>
      <address>
        <city>Orangeburg</city>
        <state>South Carolina</state>
        <zip>29118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Office of Dr.Ramesh C. Gupta MD</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Texas Clinical Research</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Investigations Of Texas</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synexus USA</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlottesville Medical Research Center LLC</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Research of Hampton Roads, Inc</name>
      <address>
        <city>Newport News</city>
        <state>Virginia</state>
        <zip>23606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spokane Joint Replacement Center</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <results_first_submitted>December 9, 2022</results_first_submitted>
  <results_first_submitted_qc>January 30, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 24, 2023</results_first_posted>
  <disposition_first_submitted>December 11, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>January 30, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 24, 2023</disposition_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Celecoxib</mesh_term>
    <mesh_term>Diclofenac</mesh_term>
    <mesh_term>Fasinumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03304379/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03304379/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 4531 participants were screened in this study. Out of which, 1650 participants were randomized to 1 of the following arms: Fasinumab (1 milligram [mg]), non-steroidal anti-inflammatory drug (NSAIDs), matched placebo, Fasinumab 3 and 6 mg. Screen failure was mostly due to inclusion criteria not met/exclusion criteria met. Eligible participants were randomized to receive placebo matched to Fasinumab/NSAIDs, NSAIDs (Diclofenac and Celecoxib) and Fasinumab 1 mg.</recruitment_details>
      <pre_assignment_details>In May 2018, the sponsor implemented an urgent safety measure to stop dosing for participants randomized to Fasinumab (6 mg and 3 mg), to prevent further randomization to these regimens across the Fasinumab program based on review of unblinded data in an ongoing study R475-PN-1523 (NCT02683239). Participants from Fasinumab 3 mg and 6 mg group were moved directly into the 20-week follow-up period.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
        </group>
        <group group_id="P2">
          <title>NSAIDs</title>
          <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
        </group>
        <group group_id="P3">
          <title>Fasinumab 1 mg</title>
          <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
        </group>
        <group group_id="P4">
          <title>Fasinumab 3 mg</title>
          <description>Participants received SC injection of Fasinumab at a dose of 3 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
        </group>
        <group group_id="P5">
          <title>Fasinumab 6 mg</title>
          <description>Participants received SC injection of Fasinumab at a dose of 6 mg Q8W up to 24 weeks, alternating with Q8W placebo injections. Participants received placebo injections at the Q4W study visits where study drug was not administered and NSAID-matching placebo oral, BID</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="308"/>
                <participants group_id="P2" count="612"/>
                <participants group_id="P3" count="612"/>
                <participants group_id="P4" count="59"/>
                <participants group_id="P5" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set (FAS)</title>
              <participants_list>
                <participants group_id="P1" count="308"/>
                <participants group_id="P2" count="612"/>
                <participants group_id="P3" count="612"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SAF)</title>
              <participants_list>
                <participants group_id="P1" count="309"/>
                <participants group_id="P2" count="609"/>
                <participants group_id="P3" count="609"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Urgent Safety Measure Set (USMS)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="59"/>
                <participants group_id="P5" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Treatment</title>
              <participants_list>
                <participants group_id="P1" count="218"/>
                <participants group_id="P2" count="436"/>
                <participants group_id="P3" count="454"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="238"/>
                <participants group_id="P2" count="471"/>
                <participants group_id="P3" count="463"/>
                <participants group_id="P4" count="42"/>
                <participants group_id="P5" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="141"/>
                <participants group_id="P3" count="149"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="9"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="66"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="4"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
        </group>
        <group group_id="B2">
          <title>NSAIDs</title>
          <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
        </group>
        <group group_id="B3">
          <title>Fasinumab 1 mg</title>
          <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
        </group>
        <group group_id="B4">
          <title>Fasinumab 3 mg</title>
          <description>Participants received SC injection of Fasinumab at a dose of 3 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
        </group>
        <group group_id="B5">
          <title>Fasinumab 6 mg</title>
          <description>Participants received SC injection of Fasinumab at a dose of 6 mg Q8W up to 24 weeks, alternating with Q8W placebo injections. Participants received placebo injections at the Q4W study visits where study drug was not administered and NSAID-matching placebo oral, BID</description>
        </group>
        <group group_id="B6">
          <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="308"/>
            <count group_id="B2" value="612"/>
            <count group_id="B3" value="612"/>
            <count group_id="B4" value="59"/>
            <count group_id="B5" value="59"/>
            <count group_id="B6" value="1650"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="308"/>
                    <count group_id="B2" value="612"/>
                    <count group_id="B3" value="612"/>
                    <count group_id="B4" value="59"/>
                    <count group_id="B5" value="59"/>
                    <count group_id="B6" value="1650"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.0" spread="9.30"/>
                    <measurement group_id="B2" value="62.3" spread="9.41"/>
                    <measurement group_id="B3" value="62.1" spread="9.13"/>
                    <measurement group_id="B4" value="62.8" spread="9.38"/>
                    <measurement group_id="B5" value="61.5" spread="9.55"/>
                    <measurement group_id="B6" value="62.2" spread="9.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="308"/>
                    <count group_id="B2" value="612"/>
                    <count group_id="B3" value="612"/>
                    <count group_id="B4" value="59"/>
                    <count group_id="B5" value="59"/>
                    <count group_id="B6" value="1650"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="222"/>
                    <measurement group_id="B2" value="418"/>
                    <measurement group_id="B3" value="436"/>
                    <measurement group_id="B4" value="36"/>
                    <measurement group_id="B5" value="34"/>
                    <measurement group_id="B6" value="1146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                    <measurement group_id="B2" value="194"/>
                    <measurement group_id="B3" value="176"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="25"/>
                    <measurement group_id="B6" value="504"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="308"/>
                    <count group_id="B2" value="612"/>
                    <count group_id="B3" value="612"/>
                    <count group_id="B4" value="59"/>
                    <count group_id="B5" value="59"/>
                    <count group_id="B6" value="1650"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="31"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="110"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="285"/>
                    <measurement group_id="B2" value="568"/>
                    <measurement group_id="B3" value="581"/>
                    <measurement group_id="B4" value="54"/>
                    <measurement group_id="B5" value="49"/>
                    <measurement group_id="B6" value="1537"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="308"/>
                    <count group_id="B2" value="612"/>
                    <count group_id="B3" value="612"/>
                    <count group_id="B4" value="59"/>
                    <count group_id="B5" value="59"/>
                    <count group_id="B6" value="1650"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="155"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="132"/>
                    <measurement group_id="B4" value="12"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="354"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="202"/>
                    <measurement group_id="B2" value="396"/>
                    <measurement group_id="B3" value="405"/>
                    <measurement group_id="B4" value="39"/>
                    <measurement group_id="B5" value="40"/>
                    <measurement group_id="B6" value="1082"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score</title>
          <description>WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.</description>
          <population>Here 'n' = number of evaluable participants at the specified time point</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="308"/>
                    <count group_id="B2" value="611"/>
                    <count group_id="B3" value="612"/>
                    <count group_id="B4" value="58"/>
                    <count group_id="B5" value="59"/>
                    <count group_id="B6" value="1648"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.42" spread="1.394"/>
                    <measurement group_id="B2" value="6.38" spread="1.344"/>
                    <measurement group_id="B3" value="6.46" spread="1.321"/>
                    <measurement group_id="B4" value="6.43" spread="1.401"/>
                    <measurement group_id="B5" value="6.54" spread="1.279"/>
                    <measurement group_id="B6" value="6.42" spread="1.344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>WOMAC Physical Function Subscale Scores</title>
          <description>WOMAC physical function subscale:17-item questionnaire used to assess degree of difficulty experienced due to OA in index joint during past 48 hours. It was calculated as mean of scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.</description>
          <population>Here 'n' = number of evaluable participants at the specified time point</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="304"/>
                    <count group_id="B2" value="609"/>
                    <count group_id="B3" value="610"/>
                    <count group_id="B4" value="58"/>
                    <count group_id="B5" value="57"/>
                    <count group_id="B6" value="1638"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.40" spread="1.495"/>
                    <measurement group_id="B2" value="6.32" spread="1.418"/>
                    <measurement group_id="B3" value="6.39" spread="1.462"/>
                    <measurement group_id="B4" value="6.50" spread="1.350"/>
                    <measurement group_id="B5" value="6.34" spread="1.392"/>
                    <measurement group_id="B6" value="6.37" spread="1.445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</title>
        <description>WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, &quot;Number of Subjects Analysed&quot; signifies those subjects who were evaluable for this endpoint. Modified full analysis set (mFAS) includes all randomized participants in FAS but excludes participants from 4 sites for which there were potential concerns regarding data quality, identified prior to database lock.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</title>
          <description>WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.</description>
          <population>This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, &quot;Number of Subjects Analysed&quot; signifies those subjects who were evaluable for this endpoint. Modified full analysis set (mFAS) includes all randomized participants in FAS but excludes participants from 4 sites for which there were potential concerns regarding data quality, identified prior to database lock.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="208"/>
                <count group_id="O2" value="439"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="208"/>
                    <count group_id="O2" value="439"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.21" spread="0.165"/>
                    <measurement group_id="O2" value="-2.84" spread="0.127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mFAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.01" spread="0.182"/>
                    <measurement group_id="O2" value="-2.78" spread="0.141"/>
                  </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>Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0003</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>MMRM</method>
            <param_type>Least Square (LS) Mean Difference</param_type>
            <param_value>-0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.971</ci_lower_limit>
            <ci_upper_limit>-0.286</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>(mFAS)&#xD;
Analyses were based on a multiple imputation approach using a MMRM model with baseline, randomization strata, baseline, treatment, visit and treatment by-visit interaction</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&gt; 0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>MMRM</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.77</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.154</ci_lower_limit>
            <ci_upper_limit>-0.383</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</title>
        <description>Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</title>
          <description>Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.</description>
          <population>This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="208"/>
                <count group_id="O2" value="439"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="207"/>
                    <count group_id="O2" value="439"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.02" spread="0.164"/>
                    <measurement group_id="O2" value="-2.65" spread="0.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mFAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="172"/>
                    <count group_id="O2" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.80" spread="0.180"/>
                    <measurement group_id="O2" value="-2.62" spread="0.138"/>
                  </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>Analyses were based on a multiple imputation approach using a Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0003</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>MMRM</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.981</ci_lower_limit>
            <ci_upper_limit>-0.290</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>(mFAS)&#xD;
Analyses were based on a multiple imputation approach using an Mixed-Effect Model With Repeated Measure (MMRM) model with baseline randomization strata, baseline, treatment, visit and treatment by-visit interaction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for significance at 0.05 level</p_value_desc>
            <method>MMRM</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.198</ci_lower_limit>
            <ci_upper_limit>-0.443</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo</title>
        <description>WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>The FAS included all randomized participants excluding participants affected by the urgent safety measure and was based on the treatment allocated (as randomized). As pre-specified in the protocol, efficacy data from participants randomized to Fasinumab 1 mg Q4W and placebo was only included in the analysis for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo</title>
          <description>WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.</description>
          <population>The FAS included all randomized participants excluding participants affected by the urgent safety measure and was based on the treatment allocated (as randomized). As pre-specified in the protocol, efficacy data from participants randomized to Fasinumab 1 mg Q4W and placebo was only included in the analysis 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="308"/>
                <count group_id="O2" value="612"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.7"/>
                    <measurement group_id="O2" value="59.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on Cochran-Mantel-Haenszel model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0013</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.581</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.195</ci_lower_limit>
            <ci_upper_limit>2.092</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</title>
        <description>The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo</title>
          <description>The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.</description>
          <population>This outcome measure examined only placebo vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="214"/>
                <count group_id="O2" value="440"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.66" spread="0.063"/>
                    <measurement group_id="O2" value="-0.81" spread="0.047"/>
                  </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>A hierarchical testing procedure was used to control type I error and handle multiple secondary endpoint analyses. Testing was then performed sequentially in the order the endpoints are reported. The hierarchical testing sequence continued only when the previous endpoint was statistically significant at 0.05 level. Analyses are based on a multiple imputation approach using Mixed-Effect Model With Repeated Measure (MMRM) model.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>= 0.0365</p_value>
            <p_value_desc>Threshold for significance at 0.05 level.</p_value_desc>
            <method>MMRM</method>
            <param_type>LS Mean Difference</param_type>
            <param_value>-0.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.28</ci_lower_limit>
            <ci_upper_limit>-0.009</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</title>
        <description>WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.</population>
        <group_list>
          <group group_id="O1">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</title>
          <description>WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.</description>
          <population>This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="426"/>
                <count group_id="O2" value="439"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="426"/>
                    <count group_id="O2" value="439"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.60" spread="0.128"/>
                    <measurement group_id="O2" value="-2.84" spread="0.127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mFAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="363"/>
                    <count group_id="O2" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.48" spread="0.140"/>
                    <measurement group_id="O2" value="-2.78" spread="0.141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</title>
        <description>Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, &quot;Number of Subjects Analysed&quot; signifies those subjects who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.</population>
        <group_list>
          <group group_id="O1">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</title>
          <description>Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.</description>
          <population>This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, &quot;Number of Subjects Analysed&quot; signifies those subjects who were evaluable for this endpoint. The modified full analysis set (mFAS) includes all randomized participants in the FAS but excludes participants from four sites for which there were potential concerns regarding data quality, identified prior to database lock.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="426"/>
                <count group_id="O2" value="439"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>FAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="426"/>
                    <count group_id="O2" value="439"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.33" spread="0.127"/>
                    <measurement group_id="O2" value="-2.65" spread="0.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>mFAS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="364"/>
                    <count group_id="O2" value="372"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.26" spread="0.140"/>
                    <measurement group_id="O2" value="-2.62" spread="0.138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</title>
        <description>The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs</title>
          <description>The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.</description>
          <population>This outcome measure examined only NSAIDs vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="427"/>
                <count group_id="O2" value="440"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.75" spread="0.048"/>
                    <measurement group_id="O2" value="-0.81" spread="0.047"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale</title>
        <description>Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale</title>
          <description>Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who were evaluable for this endpoint.</population>
          <units>Score on a Scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
                <count group_id="O2" value="449"/>
                <count group_id="O3" value="470"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.85" spread="0.130"/>
                    <measurement group_id="O2" value="-2.13" spread="0.101"/>
                    <measurement group_id="O3" value="-2.51" spread="0.100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adjudicated Arthropathy (AA) Events</title>
        <description>AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.</description>
        <time_frame>Baseline up to follow-up period (Week 44)</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Safety Analysis set (SAF) included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adjudicated Arthropathy (AA) Events</title>
          <description>AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. Safety Analysis set (SAF) included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="609"/>
                <count group_id="O3" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria</title>
        <description>DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.</description>
        <time_frame>Baseline up to follow-up period (Week 44)</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who had positive AA.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria</title>
          <description>DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received. Here, &quot;Number of Participants Analyzed&quot; signifies those participants who had positive AA.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as an AE with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.</description>
        <time_frame>Baseline up to follow-up period (Week 44)</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as an AE with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="609"/>
                <count group_id="O3" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="186"/>
                    <measurement group_id="O2" value="406"/>
                    <measurement group_id="O3" value="403"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events</title>
        <description>Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.</description>
        <time_frame>Baseline up to follow-up period (Week 44)</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events</title>
          <description>Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It was based on the actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="609"/>
                <count group_id="O3" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)</title>
        <description>Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).</description>
        <time_frame>Baseline up to Week 44</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)</title>
          <description>Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="609"/>
                <count group_id="O3" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24</title>
        <description>Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.</description>
        <time_frame>Baseline up to Week 24</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24</title>
          <description>Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="609"/>
                <count group_id="O3" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44</title>
        <description>Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.</description>
        <time_frame>Baseline up to Week 44</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44</title>
          <description>Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="609"/>
                <count group_id="O3" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)</title>
        <description>An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.</description>
        <time_frame>At Week 72</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)</title>
          <description>An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. SAF included all randomized participants from the FAS who received any study drug. It is based on the actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="609"/>
                <count group_id="O3" value="609"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Concentrations of Functional Fasinumab</title>
        <time_frame>At Weeks 0, 4, 8, 16, 24 and 44</time_frame>
        <population>Pharmacokinetic (PK) analysis set included all treated participants who received any study drug and who had at least 1 non-missing drug concentration result following the first study dose. Here, &quot;Overall Number of Participants Analyzed&quot; = participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; = participants who were evaluable at specified time points. Data was planned to be collected and analyzed for Fasinumab 1 mg Q4W arm only.</population>
        <group_list>
          <group group_id="O1">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Concentrations of Functional Fasinumab</title>
          <population>Pharmacokinetic (PK) analysis set included all treated participants who received any study drug and who had at least 1 non-missing drug concentration result following the first study dose. Here, &quot;Overall Number of Participants Analyzed&quot; = participants who were evaluable for this outcome measure and &quot;Number Analyzed&quot; = participants who were evaluable at specified time points. Data was planned to be collected and analyzed for Fasinumab 1 mg Q4W arm only.</population>
          <units>Milligrams per Liter (mg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="586"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="586"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000155" spread="0.002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="570"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0469" spread="0.0179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="543"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0644" spread="0.0275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="502"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0738" spread="0.0380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="465"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0713" spread="0.0379"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 44</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000349" spread="0.00476"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development</title>
        <description>Immunogenicity was characterized by ADA responses &amp; titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses &lt; 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, &gt;= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.</description>
        <time_frame>Baseline up to Week 44</time_frame>
        <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. The ADA analysis set included all participants who received any study drug and had at least 1 non-missing ADA result following the first dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
          </group>
          <group group_id="O2">
            <title>NSAIDs</title>
            <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
          </group>
          <group group_id="O3">
            <title>Fasinumab 1 mg</title>
            <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development</title>
          <description>Immunogenicity was characterized by ADA responses &amp; titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses &lt; 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, &gt;= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.</description>
          <population>This outcome measure examined only placebo, NSAIDs vs. fasinumab 1mg arms. The ADA analysis set included all participants who received any study drug and had at least 1 non-missing ADA result following the first dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="291"/>
                <count group_id="O2" value="568"/>
                <count group_id="O3" value="569"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Existing Immunoreactivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treated-Boosted Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-Emergent Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>First dose to week 44</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants who received subcutaneous (SC) injection of placebo matched to Fasinumab every 4 weeks (Q4W) or every 8 weeks (Q8W) alternatively or oral placebo matched to NSAID twice daily (BID) up to 24 weeks.</description>
        </group>
        <group group_id="E2">
          <title>NSAIDs</title>
          <description>Participants received oral capsule of Diclofenac at a dose of 75 mg BID or oral capsule of Celecoxib at a dose of 200 mg once daily (QD) up to 24 weeks.</description>
        </group>
        <group group_id="E3">
          <title>Fasinumab 1mg Q4W</title>
          <description>Participants received SC injection of Fasinumab at a dose of 1 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
        </group>
        <group group_id="E4">
          <title>Fasinumab 3mg Q4W</title>
          <description>Participants received SC injection of Fasinumab at a dose of 3 mg Q4W up to 24 weeks and NSAID-matching placebo oral, BID</description>
        </group>
        <group group_id="E5">
          <title>Fasinumab 6mg Q8W</title>
          <description>Participants received SC injection of Fasinumab at a dose of 6 mg Q8W up to 24 weeks, alternating with Q8W placebo injections. Participants received placebo injections at the Q4W study visits where study drug was not administered and NSAID-matching placebo oral, BID</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="609"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="609"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="609"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hiatus hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired healing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Peritonsillar abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Wound infection staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>COVID-19 pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Meningitis viral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Femur fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Fractured sacrum</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tendon injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Osteoporotic fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Rapidly progressive osteoarthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="609"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Spinal synovial cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Bursitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Joint range of motion decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Subchondral insufficiency fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Invasive papillary breast carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Trigeminal neuralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pseudostroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device loosening</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Device dislocation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depressed mood</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometrial hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Uterine prolapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Breast cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Joint arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Knee arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="609"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="609"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hip arthroplasty</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="609"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (23.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="121" subjects_at_risk="309"/>
                <counts group_id="E2" subjects_affected="263" subjects_at_risk="609"/>
                <counts group_id="E3" subjects_affected="261" subjects_at_risk="609"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="58"/>
                <counts group_id="E5" subjects_affected="15" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="29" subjects_affected="25" subjects_at_risk="309"/>
                <counts group_id="E2" events="39" subjects_affected="35" subjects_at_risk="609"/>
                <counts group_id="E3" events="57" subjects_affected="50" subjects_at_risk="609"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="26" subjects_affected="22" subjects_at_risk="309"/>
                <counts group_id="E2" events="44" subjects_affected="38" subjects_at_risk="609"/>
                <counts group_id="E3" events="35" subjects_affected="29" subjects_at_risk="609"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="309"/>
                <counts group_id="E2" events="31" subjects_affected="30" subjects_at_risk="609"/>
                <counts group_id="E3" events="33" subjects_affected="30" subjects_at_risk="609"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="309"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="609"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="609"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="309"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="609"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="609"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="309"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="609"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="609"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="58"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="53" subjects_affected="36" subjects_at_risk="309"/>
                <counts group_id="E2" events="102" subjects_affected="78" subjects_at_risk="609"/>
                <counts group_id="E3" events="109" subjects_affected="82" subjects_at_risk="609"/>
                <counts group_id="E4" events="7" subjects_affected="4" subjects_at_risk="58"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="17" subjects_affected="17" subjects_at_risk="309"/>
                <counts group_id="E2" events="60" subjects_affected="44" subjects_at_risk="609"/>
                <counts group_id="E3" events="51" subjects_affected="46" subjects_at_risk="609"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="58"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="113" subjects_affected="48" subjects_at_risk="309"/>
                <counts group_id="E2" events="210" subjects_affected="107" subjects_at_risk="609"/>
                <counts group_id="E3" events="224" subjects_affected="95" subjects_at_risk="609"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="58"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trials Administrator</name_or_title>
      <organization>Regeneron Pharmaceuticals, Inc.</organization>
      <phone>844-734-6643</phone>
      <email>clinicaltrials@regeneron.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/NCT03304379
org study id: R475-OA-1688
secondary id: 2017-001702-15
nct id: NCT03304379
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The primary objective of the study is to evaluate the efficacy of fasinumab compared to
      placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis
      (OA) of the knee or hip.

      The secondary objectives of the study are:

        -  To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs
           (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the
           knee or hip

        -  To assess the safety and tolerability of fasinumab compared to placebo and compared to
           NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee
           or hip
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
time frame: Baseline up to Week 24
description: WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
measure: Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
time frame: Baseline up to Week 24
description: Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
measure: Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo
time frame: Baseline up to Week 24
description: WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index knee during past 48 hours. It was calculated as mean of the scores from 5 individual questions scored on a NRS of 0 (minimum pain) to 10 (maximum pain), where higher scores indicate more pain.
measure: Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo
time frame: Baseline up to Week 24
description: The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
measure: Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
time frame: Baseline up to Week 24
description: WOMAC pain subscale is a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in the past 48 hours. It is calculated as the mean of the scores from the 5 individual questions scored on a NRS of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.
measure: Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
time frame: Baseline up to Week 24
description: Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.
measure: Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs
time frame: Baseline up to Week 24
description: The PGA was a patient-rated assessment of current disease state on a 5-point Likert scale where 1 = very good (asymptomatic and no limitation of normal activities), 2 = good (mild symptoms and no limitation of normal activities), 3 = fair (moderate symptoms and limitation of some normal activities), 4 = poor (Severe symptoms and inability to carry out most normal activities) and, 5 =very poor (Very severe symptoms which were intolerable and inability to carry out all normal activities). Higher score indicated severe condition.
measure: Change From Baseline in Weekly Average Walking Index Joint Pain Score up to Week 24 by Using the Numeric Rating Scale (NRS) Pain Scale
time frame: Baseline up to Week 24
description: Participants reported weekly average walking index joint pain based on NRS. The NRS was nationally recognized numeric scale from 0 to 10, where 0 would demonstrate no pain, 1 to 3 would demonstrate mild pain, 4 to 6 would be moderate pain, 7 to 9 would be severe pain and 10 would be the worst pain possible. Higher score indicated greater pain.
measure: Number of Participants With Adjudicated Arthropathy (AA) Events
time frame: Baseline up to follow-up period (Week 44)
description: AA was a composite term that encompasses the following conditions: Rapidly progressive Osteoarthritis (OA) type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
measure: Number of Participants With AA Events Meeting Destructive Arthropathy (DA) Criteria
time frame: Baseline up to follow-up period (Week 44)
description: DA is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
time frame: Baseline up to follow-up period (Week 44)
description: An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a study drug which may or may not have a causal relationship with the study drug. TEAE was defined as an AE with an onset that occurs after receiving study drug. A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious TEAEs.
measure: Number of Participants With Sympathetic Nervous System (SNS) Dysfunction Events
time frame: Baseline up to follow-up period (Week 44)
description: Potential events of SNS dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
measure: Number of Participants With At-least One Peripheral Sensory Adverse Events (AEs)
time frame: Baseline up to Week 44
description: Any participants with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an Adverse Events of Special Interest (AESI).
measure: Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 24
time frame: Baseline up to Week 24
description: Number of participants who underwent a JR surgery from baseline up to Week 24 were reported.
measure: Number of Participants Who Underwent a Joint Replacements (JR) Surgery From Baseline up to Week 44
time frame: Baseline up to Week 44
description: Number of participants who underwent a JR surgery from baseline up to follow-up period (Week 44) were reported.
measure: Number of Participants With Joint Replacement (JR) Surgery Reported at End of Study (EOS) (Week 72)
time frame: At Week 72
description: An EOS phone contact was conducted at Week 72 following the last dose of study drug (Week 24) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
measure: Serum Concentrations of Functional Fasinumab
time frame: At Weeks 0, 4, 8, 16, 24 and 44
measure: Number of Participants With At-least One Positive Anti-Drug Antibody (ADA) Development
time frame: Baseline up to Week 44
description: Immunogenicity was characterized by ADA responses & titers. Responses categories: Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses < 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, >= 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response post first dose when baseline results = negative or missing.
arm group label: Dosing regimen 1
arm group type: Experimental
arm group label: Dosing regimen 2
arm group type: Experimental
arm group label: Dosing regimen 3
arm group type: Experimental
arm group label: Dosing regimen 4
arm group type: Experimental
intervention type: Drug
intervention name: Fasinumab
description: Solution for injection in pre-filled syringe
arm group label: Dosing regimen 1
other name: REGN475
other name: MT-5547
intervention type: Other
intervention name: Diclofenac
description: NSAID active comparator (capsule)
arm group label: Dosing regimen 2
other name: ZORVOLEX
intervention type: Other
intervention name: Celecoxib
description: NSAID active comparator (capsule)
arm group label: Dosing regimen 3
other name: CELEBREX
intervention type: Drug
intervention name: Matching placebo
description: Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
arm group label: Dosing regimen 1
arm group label: Dosing regimen 2
arm group label: Dosing regimen 3
arm group label: Dosing regimen 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trial Management
role: Study Director
affiliation: Regeneron Pharmaceuticals
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis, Hip
mesh term: Celecoxib
mesh term: Diclofenac
mesh term: Fasinumab
provided document: 
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point of contact: 