<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/NCT03251482</url>
  </required_header>
  <id_info>
    <org_study_id>CR108344</org_study_id>
    <secondary_id>2016-004550-15</secondary_id>
    <secondary_id>64179375THR2001</secondary_id>
    <nct_id>NCT03251482</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery</brief_title>
  <acronym>TEXT-TKR</acronym>
  <official_title>A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary purpose of Part 1 in this study is to assess the safety and tolerability of&#xD;
      JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite&#xD;
      of major, clinically relevant non-major, and minimal bleeding events) for the selection of&#xD;
      doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of&#xD;
      JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal&#xD;
      deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated&#xD;
      leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study has 2 parts, dose escalation and dose-response evaluation, and will be conducted&#xD;
      in participants undergoing primary unilateral elective Total Knee Replacement (TKR) surgery.&#xD;
      Participants will participate in either Part 1 or Part 2 of study only. The study will be&#xD;
      conducted in 3 phases: an up to 30-day screening phase before surgery, a 14-day double-blind&#xD;
      dosing phase, and a 16-week follow-up phase. Safety evaluations will include monitoring of&#xD;
      all nonserious and serious adverse events, clinical laboratory tests, vital signs&#xD;
      measurements, and physical examinations. Pharmacokinetics (dense and sparse), pharmacodynamic&#xD;
      (PD), health resource utilization, and immunogenicity samples will also be assessed. The&#xD;
      total study duration of participant's participation in Part 1 or part 2 after randomization&#xD;
      will be approximately 18 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 13, 2017</start_date>
  <completion_date type="Actual">November 5, 2018</completion_date>
  <primary_completion_date type="Actual">November 5, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Double Blinded</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Major Bleeding Event (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 and 14 (visit observation period)</time_frame>
    <description>Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Minimal Bleeding Events (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Major VTE (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with nonfatal PE (adjudicated by CEC) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Death (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with death (adjudicated by CEC) were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Proximal and Distal DVT (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Distal DVT (CEC-adjudicated)</measure>
    <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
    <description>Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.</description>
  </secondary_outcome>
  <number_of_arms>11</number_of_arms>
  <enrollment type="Actual">308</enrollment>
  <condition>VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery</condition>
  <arm_group>
    <arm_group_label>Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenously (IV) or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 0.6 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 1.2 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 Dose to be determined (TBD) based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 Dose A mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 Dose B mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 Dose C mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 Dose D mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive JNJ-64179375 placebo (saline) IV as a single dose on Day 1 and apixaban 2.5 mg orally twice a day for 10 to 14 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64179375 0.3 mg/kg</intervention_name>
    <description>JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1.</description>
    <arm_group_label>Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64179375 0.6 mg/kg</intervention_name>
    <description>JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.</description>
    <arm_group_label>Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64179375 1.2 mg/kg</intervention_name>
    <description>JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.</description>
    <arm_group_label>Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64179375 (Dose to be Determined)</intervention_name>
    <description>JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.</description>
    <arm_group_label>Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64179375 A mg/kg</intervention_name>
    <description>JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.</description>
    <arm_group_label>Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64179375 B mg/kg</intervention_name>
    <description>JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.</description>
    <arm_group_label>Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64179375 C mg/kg</intervention_name>
    <description>JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.</description>
    <arm_group_label>Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64179375 D mg/kg</intervention_name>
    <description>JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.</description>
    <arm_group_label>Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo JNJ-64179375</intervention_name>
    <description>Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.</description>
    <arm_group_label>Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban placebo</intervention_name>
    <description>Matching apixaban placebo administered orally twice a day for 10 to 14 days.</description>
    <arm_group_label>Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo</arm_group_label>
    <arm_group_label>Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo</arm_group_label>
    <arm_group_label>Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo</arm_group_label>
    <arm_group_label>Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apixaban 2.5 mg</intervention_name>
    <description>Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.</description>
    <arm_group_label>Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)</arm_group_label>
    <arm_group_label>Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Weight greater than or equal to (&gt;=) 40 kg to less than or equal to (&lt;=) 150 kilogram&#xD;
             (kg)&#xD;
&#xD;
          -  Medically appropriate for postoperative anticoagulant prophylaxis as determined by the&#xD;
             investigator&#xD;
&#xD;
          -  Has undergone an elective primary unilateral total knee replacement (TKR)&#xD;
&#xD;
          -  Before randomization, a woman must not be of childbearing potential defined as&#xD;
             postmenopausal (defined as no menses for 12 months without an alternative medical&#xD;
             cause) and/ or permanently sterile (include hysterectomy, bilateral salpingectomy,&#xD;
             bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy)&#xD;
&#xD;
          -  Contraceptive use by men should be consistent with local regulations regarding the use&#xD;
             of contraceptive methods for participant participating in clinical studies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition for which the use of apixaban is not recommended in the opinion of the&#xD;
             investigator&#xD;
&#xD;
          -  Bilateral, revision or unicompartmental procedure&#xD;
&#xD;
          -  Known or suspected hypersensitivity or intolerance to any biologic medication or known&#xD;
             allergies or clinically significant reactions to murine, chimeric, or human proteins,&#xD;
             monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375&#xD;
&#xD;
          -  Unable to undergo venography&#xD;
&#xD;
          -  Known previous deep vein thrombosis (DVT) in either lower extremity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbor-UCLA Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Metro Orthopedics, PC</name>
      <address>
        <city>Englewood</city>
        <state>Colorado</state>
        <zip>80113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Research Associates, LLC</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avanza research</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Orthopedic and Joint Replacement Center</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hermann Memorial City Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Italiano de Buenos Aires</name>
      <address>
        <city>Caba</city>
        <zip>C1199ABB</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Adventista Belgrano</name>
      <address>
        <city>Caba</city>
        <zip>C1430EGF</zip>
        <country>Argentina</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Hospital San Roque</name>
      <address>
        <city>Córdoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clínica Chutro</name>
      <address>
        <city>Córdoba</city>
        <zip>X5000EPU</zip>
        <country>Argentina</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Hospital Italiano La Plata</name>
      <address>
        <city>La Plata</city>
        <zip>B1900AXI</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Britanico de Rosario</name>
      <address>
        <city>Rosario</city>
        <zip>2000</zip>
        <country>Argentina</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio San Miguel</name>
      <address>
        <city>San Miguel</city>
        <zip>B1663GFL</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Middelheim</name>
      <address>
        <city>Antwerpen</city>
        <zip>2020</zip>
        <country>Belgium</country>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ZNA Jan Palfijn</name>
      <address>
        <city>Merksem</city>
        <zip>2170</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Minas Gerais (UFMG) - Faculdade de Medicina</name>
      <address>
        <city>Belo Horizonte</city>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sao Francisco de Assis</name>
      <address>
        <city>Belo Horizonte</city>
        <zip>30360-290</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unicamp - Hospital de Clinicas</name>
      <address>
        <city>Campinas</city>
        <zip>13083-888</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniort.e - Hospital de ortopedia</name>
      <address>
        <city>Londrina</city>
        <zip>86050-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmandade da Santa Casa de Misericórdia de Marília</name>
      <address>
        <city>Marilia</city>
        <zip>17515-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericordia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90020-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital e Maternidade Dr Christovão da Gama</name>
      <address>
        <city>Santo André</city>
        <zip>09030-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Estadual Mario covas</name>
      <address>
        <city>Santo André</city>
        <zip>09190-615</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>05403-010</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment Russe</name>
      <address>
        <city>Russe</city>
        <zip>7002</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Acibadem City Clinic Tokuda Hospital</name>
      <address>
        <city>Sofa</city>
        <zip>1407</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Military Medical Academy</name>
      <address>
        <city>Sofia</city>
        <zip>1606</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeridge Health Ajax</name>
      <address>
        <city>Ajax</city>
        <state>Ontario</state>
        <zip>L1S 2J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Source Trial Solutions Inc.</name>
      <address>
        <city>Kitchener</city>
        <state>Ontario</state>
        <zip>N2M 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital Research Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Cliniche Humanitas Gavazzeni</name>
      <address>
        <city>Bergamo</city>
        <zip>24125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Ortopedico Rizzoli</name>
      <address>
        <city>Bologna</city>
        <zip>40136</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Careggi</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Policlinico San Donato</name>
      <address>
        <city>S. Donato Milanese</city>
        <zip>20097</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Città della Salute e della Scienza</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Mauriziano (Torino)</name>
      <address>
        <city>Torino</city>
        <zip>10128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Matsudo City General Hospital</name>
      <address>
        <city>Chiba</city>
        <zip>270-2296</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hakodate Goryokaku Hospital</name>
      <address>
        <city>Hakodate</city>
        <zip>040-8611</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ritsuzankai Iida Hospital</name>
      <address>
        <city>Iida-shi</city>
        <zip>395-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Itami City Hospital</name>
      <address>
        <city>Itami-shi</city>
        <zip>664-8540</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonemori Hospital</name>
      <address>
        <city>Kagoshima-shi</city>
        <zip>890-0062</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bange Kousei General Hospital</name>
      <address>
        <city>Kawanuma-Gun</city>
        <zip>969-6593</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Saiseikai Nakatsu Hospital</name>
      <address>
        <city>Osaka-shi</city>
        <zip>530-0012</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Rosai Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>591-8025</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima Municipal Hospital</name>
      <address>
        <city>Tokushima-shi</city>
        <zip>770-0812</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuaikai Tomishiro Central Hospital</name>
      <address>
        <city>Tomishiro</city>
        <zip>901-0243</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Hospital of Liepaja</name>
      <address>
        <city>Liepaja</city>
        <zip>LV-3414</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riga 2nd Hospital</name>
      <address>
        <city>Riga</city>
        <zip>LV1004</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Traumatology and Orthopedics</name>
      <address>
        <city>Riga</city>
        <zip>LV1005</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidzemes Hospital</name>
      <address>
        <city>Valmiera</city>
        <zip>LV-4201</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of Lithuanian University of Health Sciences Kaunas Clinics</name>
      <address>
        <city>Kaunas</city>
        <zip>LT50161</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klaipeda University Hospital</name>
      <address>
        <city>Klaipeda</city>
        <zip>92288</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Malaya Medical Center</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Tengku Ampuan Afzan</name>
      <address>
        <city>Kuantan</city>
        <zip>25100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Miri</name>
      <address>
        <city>Miri</city>
        <zip>98000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sibu</name>
      <address>
        <city>Sibu</city>
        <zip>96000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sultan Abdul Halim</name>
      <address>
        <city>Sungai Petani</city>
        <zip>08000</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Ortopedii i Traumatologii UMB</name>
      <address>
        <city>Bialystok</city>
        <zip>15-276</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Ortopedii i Traumatologii - Szpital Ogolny im. W.Ginela</name>
      <address>
        <city>Grajewo</city>
        <zip>19-203</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Ortopedii Gornoslaskie Centrum Medyczne</name>
      <address>
        <city>Katowice</city>
        <zip>40-635</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Ortopedii i Traumatologii Szpital Specjalistyczny im. L.Rydygiera</name>
      <address>
        <city>Krakow</city>
        <zip>31-826</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SP ZOZ MSWiA w Krakowie Oddzial Urazowo-Ortopedyczny</name>
      <address>
        <city>Krakow</city>
        <zip>33-332</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CSK UM Klinika Ortopedii</name>
      <address>
        <city>Lodz</city>
        <zip>92-213</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Urazowo-Ortopedyczny Wojewodzki Szpital Specjalistyczny</name>
      <address>
        <city>Lublin</city>
        <zip>20-718</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Ortopedii I Traumatologii,Szpital Kliniczny Ortopedyczno-Rehabilitacyjny UM</name>
      <address>
        <city>Poznan</city>
        <zip>61-545</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Ortopedii Specjalistyczny Szpital im. E.Szczeklika</name>
      <address>
        <city>Tarnow</city>
        <zip>33-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oddzial Chirurgii Urazowej iOrtopedycznej,Wojewodzki Szpital Brodnowski, SPZOZ</name>
      <address>
        <city>Warszawa</city>
        <zip>03-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnaul Federal Center of Traumatology, Orthopedics and Endoprothesis replacement</name>
      <address>
        <city>Barnaul</city>
        <zip>656045</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Ilizarov Scientific Center For Restorative Traumatology And Ortopaedics</name>
      <address>
        <city>Kurgan</city>
        <zip>640014</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow City Clinical Hospital #1 n.a. N.I.Pirogov</name>
      <address>
        <city>Moscow</city>
        <zip>117049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Privolzhsky Research Medical University of Ministry of Health of Russian Federation</name>
      <address>
        <city>Nizhny Novgorod</city>
        <zip>603155</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg State Medical Institution City Multifunctional Hospital #2</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194354</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Research Institute of Traumatology and Orthopaedics n.a.R.R.Vreden</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>195427</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Healthcare Institution Samara Regional Clinical Hospital named after V.D.Seredavin</name>
      <address>
        <city>Samara</city>
        <zip>443095</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Emergency Hospital n.a. N.V. Solovyev</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Germans Trias I Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. Fund. Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Corporacio Sanitari Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Clinico Univ. de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp. Univ. I Politecni La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ankara Numune Research and Training Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dışkapı Yıldırım Beyazıd Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yıldırım Beyazıt University Yenimahalle Training and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06370</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yildirim Beyazit University Medical Faculty Ankara Atatürk Research and Training Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06800</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bakirkoy Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34147</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umraniye Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34764</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Izmir Tepecik Training and Research Hospital</name>
      <address>
        <city>Izmir</city>
        <zip>35180</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council</name>
      <address>
        <city>Cherkasy</city>
        <zip>18009</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ivano-Frankivsk Regional Clinical Hospital</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76008</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Spine and JointPathology named after Prof.Sytenko of NationalAcademy of MedicalSciences</name>
      <address>
        <city>Kharkiv</city>
        <zip>61024</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Institution of Health Care 'Kharkiv Regional Clinical Traumatology Hospital'</name>
      <address>
        <city>Kharkiv</city>
        <zip>61176</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyiv Regional Clinical Hospital</name>
      <address>
        <city>Kyiv</city>
        <zip>04107</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Communal Institution of Lviv Regional Council 'Lypa Lviv Regional Hospital'</name>
      <address>
        <city>Lviv-Vynnyky</city>
        <zip>79495</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinnytsya Regional Clinical Hospital named after M.I.Pirogov</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21018</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zaporizhzhia Regional Clinical Hospital</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69600</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Latvia</country>
    <country>Lithuania</country>
    <country>Malaysia</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Czechia</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Portugal</country>
    <country>Romania</country>
    <country>Sweden</country>
    <country>Thailand</country>
  </removed_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <results_first_submitted>November 5, 2019</results_first_submitted>
  <results_first_submitted_qc>November 5, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 25, 2019</results_first_posted>
  <last_update_submitted>November 5, 2019</last_update_submitted>
  <last_update_submitted_qc>November 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apixaban</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>September 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03251482/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>October 18, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03251482/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study was planned to be conducted in 2 parts: Part 1 (Dose- Escalation) and Part 2 (Dose-Response). After completion of Part 1, the sponsor made the decision to not move forward with Part 2 as there was sufficient data to make a determination of efficacy in Part 1. Part 2 was not conducted, hence endpoints for Part 2 are not reported.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
        </group>
        <group group_id="P2">
          <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="P3">
          <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="P4">
          <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="P5">
          <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
          <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="122"/>
                <participants group_id="P5" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="42"/>
                <participants group_id="P4" count="122"/>
                <participants group_id="P5" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="43"/>
                <participants group_id="P4" count="122"/>
                <participants group_id="P5" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</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>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="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>
      <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).</population>
      <group_list>
        <group group_id="B1">
          <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
        </group>
        <group group_id="B2">
          <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="B3">
          <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="B4">
          <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="B5">
          <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
          <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</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="38"/>
            <count group_id="B2" value="40"/>
            <count group_id="B3" value="42"/>
            <count group_id="B4" value="122"/>
            <count group_id="B5" value="63"/>
            <count group_id="B6" value="305"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.2" spread="7.53"/>
                    <measurement group_id="B2" value="65.8" spread="8.14"/>
                    <measurement group_id="B3" value="66.9" spread="6.41"/>
                    <measurement group_id="B4" value="67.2" spread="8.84"/>
                    <measurement group_id="B5" value="65.1" spread="7.01"/>
                    <measurement group_id="B6" value="66.4" spread="7.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="99"/>
                    <measurement group_id="B5" value="42"/>
                    <measurement group_id="B6" value="222"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="23"/>
                    <measurement group_id="B5" value="21"/>
                    <measurement group_id="B6" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <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="9"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="39"/>
                    <measurement group_id="B4" value="110"/>
                    <measurement group_id="B5" value="54"/>
                    <measurement group_id="B6" value="278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unspecified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bulgaria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <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="5"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="4"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lithuania</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaysia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Russian Federation</title>
              <category_list>
                <category>
                  <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="9"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ukraine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="20"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="12"/>
                    <measurement group_id="B6" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)</title>
        <description>Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)</title>
          <description>Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.</description>
          <population>Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).</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="38"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="122"/>
                <count group_id="O5" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)</title>
        <description>Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>Modified Intent-to-treat (mITT) analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death adjudicated by CEC.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)</title>
          <description>Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
          <population>Modified Intent-to-treat (mITT) analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death adjudicated by CEC.</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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="97"/>
                <count group_id="O5" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="31"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)</title>
        <description>Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)</title>
          <description>Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active 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="38"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="122"/>
                <count group_id="O5" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Major Bleeding Event (CEC-adjudicated)</title>
        <description>Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Bleeding Event (CEC-adjudicated)</title>
          <description>Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active 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="38"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="122"/>
                <count group_id="O5" value="63"/>
              </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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)</title>
        <description>Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)</title>
          <description>Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active 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="38"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="122"/>
                <count group_id="O5" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)</title>
        <description>Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
        <time_frame>Up to Day 10 and 14 (visit observation period)</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)</title>
          <description>Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active 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="38"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="122"/>
                <count group_id="O5" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Minimal Bleeding Events (CEC-adjudicated)</title>
        <description>Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Minimal Bleeding Events (CEC-adjudicated)</title>
          <description>Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.</description>
          <population>Safety analysis set included all randomized participants who received at least 1 dose (partial or complete) of active 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="38"/>
                <count group_id="O2" value="40"/>
                <count group_id="O3" value="42"/>
                <count group_id="O4" value="122"/>
                <count group_id="O5" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Major VTE (CEC-adjudicated)</title>
        <description>Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event or any death.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Major VTE (CEC-adjudicated)</title>
          <description>Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
          <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event or any death.</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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="97"/>
                <count group_id="O5" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)</title>
        <description>Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)</title>
          <description>Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
          <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="97"/>
                <count group_id="O5" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptomatic</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 group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)</title>
        <description>Number of participants with nonfatal PE (adjudicated by CEC) were reported.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)</title>
          <description>Number of participants with nonfatal PE (adjudicated by CEC) were reported.</description>
          <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="97"/>
                <count group_id="O5" value="49"/>
              </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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Death (CEC-adjudicated)</title>
        <description>Number of participants with death (adjudicated by CEC) were reported.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Death (CEC-adjudicated)</title>
          <description>Number of participants with death (adjudicated by CEC) were reported.</description>
          <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="97"/>
                <count group_id="O5" value="49"/>
              </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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Proximal and Distal DVT (CEC-adjudicated)</title>
        <description>Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Proximal and Distal DVT (CEC-adjudicated)</title>
          <description>Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.</description>
          <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="97"/>
                <count group_id="O5" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptomatic</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 group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Distal DVT (CEC-adjudicated)</title>
        <description>Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.</description>
        <time_frame>Up to Day 10 to 14 (visit observation period)</time_frame>
        <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</population>
        <group_list>
          <group group_id="O1">
            <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
          </group>
          <group group_id="O2">
            <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O3">
            <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O4">
            <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
            <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
          </group>
          <group group_id="O5">
            <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
            <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Distal DVT (CEC-adjudicated)</title>
          <description>Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.</description>
          <population>mITT analysis set included all randomized participants with an evaluable venography assessment or a confirmed symptomatic VTE event, or any death.</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="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="97"/>
                <count group_id="O5" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Asymptomatic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="24"/>
                    <measurement group_id="O5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptomatic</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 group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 18 weeks</time_frame>
      <desc>Safety Analysis set included all randomized participants who received at least 1 dose (partial or complete) of active study drug (JNJ-64179375 or apixaban).</desc>
      <group_list>
        <group group_id="E1">
          <title>JNJ-64179375 0.3 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single intravenous (IV) infusion of JNJ-64179375 0.3 milligrams per kilogram (mg/kg) on Day 1 and matching apixaban placebo tablets orally twice daily (BID) for 10 to 14 days.</description>
        </group>
        <group group_id="E2">
          <title>JNJ-64179375 0.6 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 0.6 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="E3">
          <title>JNJ-64179375 1.2 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 1.2 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="E4">
          <title>JNJ-64179375 1.8 mg/kg and Apixaban Placebo</title>
          <description>Participants received a single IV infusion of JNJ-64179375 1.8 mg/kg on Day 1 and matching apixaban placebo tablets orally BID for 10 to 14 days.</description>
        </group>
        <group group_id="E5">
          <title>Apixaban 2.5 mg and JNJ-64179375 Placebo IV</title>
          <description>Participants received a single IV infusion of matching JNJ-64179375 placebo on Day 1 and apixaban 2.5 mg tablet orally BID for 10 to 14 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA Version 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Primary Hyperaldosteronism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Impaired Healing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tendon Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Wound Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Joint Contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Bladder Cancer Stage 0, with Cancer in Situ</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bloody Discharge</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Post Thrombotic Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA Version 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="37" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="20" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Aphthous Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Food Poisoning</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter Site Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Fat Necrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Feeling Hot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Impaired Healing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Injection Site Irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Peripheral Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Patella Fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Post Procedural Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Post Procedural Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Procedural Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Procedural Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Tendon Rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Wound Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Blood Thyroid Stimulating Hormone Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Blood Triglycerides Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Body Temperature Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Cardiovascular Evaluation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Gamma-Glutamyltransferase Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Platelet Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pain in Extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness Exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dizziness Postural</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal Colic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Decubitus Ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dermatitis Contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Dry Skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Pruritus Generalised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Rash Pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bloody Discharge</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="3" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Peripheral Venous Disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="40"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="42"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="122"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="63"/>
              </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>If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Senior Director</name_or_title>
      <organization>Janssen Research &amp; Development, LLC</organization>
      <phone>844-434-4210</phone>
      <email>ClinicalTrialDisclosure@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03251482
org study id: CR108344
secondary id: 2016-004550-15
secondary id: 64179375THR2001
nct id: NCT03251482
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The primary purpose of Part 1 in this study is to assess the safety and tolerability of
      JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite
      of major, clinically relevant non-major, and minimal bleeding events) for the selection of
      doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of
      JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal
      deep vein thrombosis [DVT] [asymptomatic confirmed by venography assessment of the operated
      leg or objectively confirmed symptomatic], nonfatal pulmonary embolism [PE], or any death).
This study has 2 parts, dose escalation and dose-response evaluation, and will be conducted
      in participants undergoing primary unilateral elective Total Knee Replacement (TKR) surgery.
      Participants will participate in either Part 1 or Part 2 of study only. The study will be
      conducted in 3 phases: an up to 30-day screening phase before surgery, a 14-day double-blind
      dosing phase, and a 16-week follow-up phase. Safety evaluations will include monitoring of
      all nonserious and serious adverse events, clinical laboratory tests, vital signs
      measurements, and physical examinations. Pharmacokinetics (dense and sparse), pharmacodynamic
      (PD), health resource utilization, and immunogenicity samples will also be assessed. The
      total study duration of participant's participation in Part 1 or part 2 after randomization
      will be approximately 18 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Double Blinded
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Number of Participants With Treatment-emergent Bleeding Events (Clinical Events Committee [CEC]- Adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with treatment-emergent bleeding events (BE) (adjudicated by CEC) were reported. Bleeding event was defined as the composite of major, clinically relevant nonmajor (CRNM), and minimal bleeding events assessed through the Day 10 to 14.
measure: Number of Participants With Total Venous Thromboembolism (VTE) (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with total VTE were reported. Total VTE was defined as the composite of CEC-adjudicated proximal and/or distal deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), nonfatal pulmonary embolism (PE), or any death assessed through the Day 10 to 14 visit. 1 participant had an asymptomatic distal clot in the non-operated leg which is not counted in the Total VTE and 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
measure: Number of Participants With Composite of Major and CRNM Bleeding Events (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with composite of major and CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
measure: Number of Participants With Major Bleeding Event (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with major bleeding events (BE) (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in hemoglobin (Hb) level of 20 grams per liter (g/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability.
measure: Number of Participants With Clinically Relevant Non-major (CRNM) Bleeding Events (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with CRNM bleeding events (adjudicated by CEC) were reported. CRNM bleeding was defined as acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major bleeding event and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
measure: Number of Participants With Major Bleeding or CRNM Bleeding Events (CEC-adjudicated)
time frame: Up to Day 10 and 14 (visit observation period)
description: Number of participants with major bleeding or CRNM bleeding events (adjudicated by CEC) were reported. Major Bleeding: Fatal bleeding; Bleeding that is symptomatic and occurs in critical area/organ and/or; Extrasurgical site bleeding causing fall in Hb level of 20 g/L or more, or leading to transfusion of 2 or more units of whole blood or red cells with temporal association within 24-48 hours to bleeding, and/or; Surgical site bleeding that requires second intervention open, arthroscopic, endovascular, or hemarthrosis resulting in prolonged hospitalization or a deep wound infection and/or; Surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability. CRNM bleeding: acute clinically overt bleeding that does not satisfy additional criteria required for bleeding event to be defined as major BE and meets at least 1 of following criteria: Epistaxis, Gastrointestinal bleed, Hematuria, Bruising/ecchymosis, Hemoptysis, Hematoma.
measure: Number of Participants With Minimal Bleeding Events (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with minimal bleeding events (adjudicated by CEC) were reported. Minimal bleeding event was defined as any bleeding event not met major or CRNM criteria.
measure: Number of Participants With Major VTE (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with major VTE (adjudicated by CEC) were reported. Major VTE was defined as a composite of proximal DVT (asymptomatic confirmed by venography or objectively confirmed symptomatic), nonfatal PE, or any death. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
measure: Number of Participants With Proximal Deep Vein Thrombosis (DVT) (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with proximal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
measure: Number of Participants With Nonfatal Pulmonary Embolism (PE) (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with nonfatal PE (adjudicated by CEC) were reported.
measure: Number of Participants With Death (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with death (adjudicated by CEC) were reported.
measure: Number of Participants With Proximal and Distal DVT (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with proximal and distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic. 2 participants had symptomatic proximal clots at the Day 10 to 14 venography and are counted in both the asymptomatic proximal and symptomatic proximal groups.
measure: Number of Participants With Distal DVT (CEC-adjudicated)
time frame: Up to Day 10 to 14 (visit observation period)
description: Number of participants with distal DVT (adjudicated by CEC) were reported. DVT asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic.
arm group label: Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)
arm group type: Experimental
description: Participants will receive JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenously (IV) or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
arm group label: Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)
arm group type: Experimental
description: Participants will receive JNJ-64179375 0.6 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
arm group label: Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)
arm group type: Experimental
description: Participants will receive JNJ-64179375 1.2 mg/kg IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
arm group label: Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)
arm group type: Experimental
description: Participants will receive JNJ-64179375 Dose to be determined (TBD) based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
arm group label: Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)
arm group type: Experimental
description: Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
arm group label: Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)
arm group type: Experimental
description: Participants will receive JNJ-64179375 Dose TBD based on preliminary data (dose may range from 0.1 to 1.8 mg/kg or any dose from the preceding cohorts) IV or JNJ-64179375 placebo (saline) IV infusion as a single dose on Day 1 and matching apixaban placebo or 2.5 mg apixaban, orally twice a day for 10 to 14 days.
arm group label: Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo
arm group type: Experimental
description: Participants will receive JNJ-64179375 Dose A mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
arm group label: Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo
arm group type: Experimental
description: Participants will receive JNJ-64179375 Dose B mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
arm group label: Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo
arm group type: Experimental
description: Participants will receive JNJ-64179375 Dose C mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
arm group label: Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo
arm group type: Experimental
description: Participants will receive JNJ-64179375 Dose D mg/kg (TBD based on review of data from Part 1) IV as a single dose on Day 1 and apixaban placebo orally twice a day for 10 to 14 days.
arm group label: Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg
arm group type: Experimental
description: Participants will receive JNJ-64179375 placebo (saline) IV as a single dose on Day 1 and apixaban 2.5 mg orally twice a day for 10 to 14 days.
intervention type: Drug
intervention name: JNJ-64179375 0.3 mg/kg
description: JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1.
arm group label: Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)
intervention type: Drug
intervention name: JNJ-64179375 0.6 mg/kg
description: JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.
arm group label: Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)
intervention type: Drug
intervention name: JNJ-64179375 1.2 mg/kg
description: JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.
arm group label: Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)
intervention type: Drug
intervention name: JNJ-64179375 (Dose to be Determined)
description: JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.
arm group label: Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)
intervention type: Drug
intervention name: JNJ-64179375 A mg/kg
description: JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.
arm group label: Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo
intervention type: Drug
intervention name: JNJ-64179375 B mg/kg
description: JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.
arm group label: Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo
intervention type: Drug
intervention name: JNJ-64179375 C mg/kg
description: JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.
arm group label: Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo
intervention type: Drug
intervention name: JNJ-64179375 D mg/kg
description: JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.
arm group label: Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo
intervention type: Drug
intervention name: Placebo JNJ-64179375
description: Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.
arm group label: Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)
arm group label: Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg
intervention type: Drug
intervention name: Apixaban placebo
description: Matching apixaban placebo administered orally twice a day for 10 to 14 days.
arm group label: Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)
arm group label: Part 2: Group A: JNJ-64179375 A mg/kg and apixaban placebo
arm group label: Part 2: Group B: JNJ-64179375 B mg/kg and apixaban placebo
arm group label: Part 2: Group C: JNJ-64179375 C mg/kg and apixaban placebo
arm group label: Part 2: Group D: JNJ-64179375 D mg/kg and apixaban placebo
intervention type: Drug
intervention name: Apixaban 2.5 mg
description: Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.
arm group label: Part 1: Cohort 1 (0.3 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Cohort 2 (0.6 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Cohort 3 (1.2 mg/kg JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 4 (JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 5 (JNJ-64179375/Apixaban)
arm group label: Part 1: Optional Cohort 6 (JNJ-64179375/Apixaban)
arm group label: Part 2: Group E: JNJ-64179375 placebo IV and apixaban 2.5 mg
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
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country: Argentina
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Italy
country: Japan
country: Latvia
country: Lithuania
country: Malaysia
country: Poland
country: Russian Federation
country: Spain
country: Turkey
country: Ukraine
country: United States
country: Czechia
country: Greece
country: Hungary
country: Portugal
country: Romania
country: Sweden
country: Thailand
responsible party type: Sponsor
mesh term: Apixaban
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