<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/NCT02227693</url>
  </required_header>
  <id_info>
    <org_study_id>E5501-J081-204</org_study_id>
    <nct_id>NCT02227693</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Diseases and Thrombocytopenia</brief_title>
  <official_title>A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Once-daily Oral Avatrombopag in Japanese Subjects With Chronic Liver Disease and Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using&#xD;
      avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver&#xD;
      disease. This study will assess the effect of avatrombopag on platelet counts in Japanese&#xD;
      subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count&#xD;
      measured at Screening and Baseline. Within the lower baseline platelet count cohort (less&#xD;
      than 40 x 10^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg&#xD;
      avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher&#xD;
      baseline platelet count cohort (from 40 to less than 50 x 10^9/L), subjects will be&#xD;
      randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag for&#xD;
      5 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will consist of Prerandomization Phase and Randomization Phase. The&#xD;
      Prerandomization Phase includes a Screening Period (Day -28 to Day -1) and a Baseline Period&#xD;
      (Day 1). During the Prerandomization Phase, participants will be divided into two cohorts&#xD;
      based on the platelet count: Low Platelet Count Cohort and High Platelet Count Cohort.&#xD;
      Participants in Low Platelet Count Cohort will be randomized to receive one of the four&#xD;
      treatments: Placebo, Avatrombopag 20 mg, Avatrombopag 40 mg, or Avatrombopag 60 mg.&#xD;
      Participants in High Platelet Count Cohort will be randomized to receive one of the three&#xD;
      treatments: Placebo, Avatrombopag 20 mg, or Avatrombopag 40 mg.&#xD;
&#xD;
      The Randomization Phase includes the Treatment Period and the Follow-up Period. The Follow-up&#xD;
      Period comprises 3 visits: Visit 4 (5 to 8 days after last dose of study drug [Study Day 10&#xD;
      to 13]), Visit 5 (12 to 15 days after last dose of study drug [Study Day 17 to 20]), and 30&#xD;
      days after receiving the last dose of study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">April 1, 2015</completion_date>
  <primary_completion_date type="Actual">April 1, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4</measure>
    <time_frame>Baseline and Visit 4 (Day 10)</time_frame>
    <description>Responders were defined as participants whose platelet count was greater than or equal to 50×10^9/liter (L) and change from baseline was at least 20×10^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit</measure>
    <time_frame>Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
    <description>Responders were defined as the participants whose platelet count greater than or equal to 50 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit</measure>
    <time_frame>Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
    <description>Responders were defined as the participants whose platelet count greater than or equal to 75 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit</measure>
    <time_frame>Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
    <description>Responders were defined as the participants whose platelet count greater than or equal to 150 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit</measure>
    <time_frame>Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
    <description>Responders were defined as the participants whose platelet count greater than or equal to 200 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet Count and Change From Baseline in Platelet Count by Visit</measure>
    <time_frame>Baseline, Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months</time_frame>
    <description>Safety assessments consisted of monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms; physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. A treatment-emergent adverse event (TEAE) was defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. For each category, a participant with two or more adverse events in that category was counted only once. Treatment-related TEAEs were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing causality.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology</measure>
    <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Clinically Significant Findings in Laboratory Values for Serum</measure>
    <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Clinically Significant Findings in Laboratory Values for Urinalysis</measure>
    <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values</measure>
    <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Markedly Abnormal Electrocardiographs</measure>
    <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Thrombocytopenia Associated With Chronic Liver Disease</condition>
  <arm_group>
    <arm_group_label>avatrombopag 20-mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) once daily on Days 1 through 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>avatrombopag 40-mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) once daily on Days 1 through 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>avatrombopag 60-mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 mg avatrombopag (3 x 20 mg tablets) once daily on Days 1 through 5</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo l</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (3 x 20-mg matching placebo tablets) once daily on Days 1 through 5</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>avatrombopag</intervention_name>
    <description>E5501 (avatrombopag) 20-mg tablets</description>
    <arm_group_label>avatrombopag 20-mg</arm_group_label>
    <arm_group_label>avatrombopag 40-mg</arm_group_label>
    <arm_group_label>avatrombopag 60-mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching 20-mg tablets</description>
    <arm_group_label>placebo l</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Japanese subjects greater than or equal to 20 years of age at Screening with chronic&#xD;
             liver disease.&#xD;
&#xD;
          2. Subjects who have a mean baseline platelet count of less than 50 x 10^9/L. Platelet&#xD;
             counts will be measured on 2 separate occasions, during the Screening Period and at&#xD;
             Baseline, and must be performed at least one day apart with neither platelet count&#xD;
             greater than 60 x 10^9/L.&#xD;
&#xD;
          3. Model For End-stage Liver Disease (MELD) score 24 at Screening.&#xD;
&#xD;
          4. If taking inhibitors of P glycoprotein (P-gp), except for verapamil, dose must be&#xD;
             stable for 7 days prior to Screening.&#xD;
&#xD;
          5. Provide written informed consent.&#xD;
&#xD;
          6. Willing and able to comply with all aspects of the protocol.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Any history of arterial or venous thrombosis, including partial or complete&#xD;
             thrombosis.&#xD;
&#xD;
          2. Evidence of thrombosis (partial or complete) in the main portal vein, portal vein&#xD;
             branches, or any part of the splenic mesenteric system at Screening.&#xD;
&#xD;
          3. Portal vein blood flow velocity rate less than 10 cm/second at Screening.&#xD;
&#xD;
          4. Hepatic encephalopathy that cannot be effectively treated.&#xD;
&#xD;
          5. Subjects with HCC with Barcelona Clinic Liver Cancer (BCLC) staging classification C&#xD;
             or D.&#xD;
&#xD;
          6. Platelet transfusion or receipt of blood products containing platelets within 7 days&#xD;
             of Screening. However packed red blood cells are permitted.&#xD;
&#xD;
          7. Heparin, warfarin, nonsteroidal anti-inflammatory drugs (NSAID), aspirin, verapamil,&#xD;
             and antiplatelet therapy with ticlopidine or glycoprotein IIb/IIIa antagonists (eg,&#xD;
             tirofiban) within 7 days of Screening.&#xD;
&#xD;
          8. Use of erythropoietin stimulating agents within 7 days of Screening.&#xD;
&#xD;
          9. Interferon (IFN) use within 14 days of Screening.&#xD;
&#xD;
         10. Estrogen-containing hormonal contraceptive or hormone replacement therapy use within&#xD;
             30 days of Screening.&#xD;
&#xD;
         11. Active infection requiring systemic antibiotic therapy within 7 days of Screening.&#xD;
             However, prophylactic use of antibiotics is permitted.&#xD;
&#xD;
         12. Alcohol abuse, alcohol dependence syndrome, drug abuse, or drug dependence within 6&#xD;
             months of the study start (unless participating in a controlled rehabilitation&#xD;
             program) or acute alcoholic hepatitis (chronic alcoholic hepatitis is allowed) within&#xD;
             6 months of the study start.&#xD;
&#xD;
         13. Known to be human immunodeficiency virus positive.&#xD;
&#xD;
         14. Any clinically significant acute or active bleeding (eg, gastrointestinal, central&#xD;
             nervous system).&#xD;
&#xD;
         15. Known history of any primary hematologic disorder (eg, immune thrombocytopenic&#xD;
             purpura, myelodysplastic syndrome).&#xD;
&#xD;
         16. Known medical history of genetic prothrombotic syndromes (eg, Factor V Leiden;&#xD;
             prothrombin G20210A; ATIII deficiency etc.)&#xD;
&#xD;
         17. Subjects with a history of significant cardiovascular disease (eg, congestive heart&#xD;
             failure New York Heart Association Grade III/IV, arrhythmia known to increase the risk&#xD;
             of thromboembolic events [eg, atrial fibrillation], coronary artery stent placement,&#xD;
             angioplasty, and coronary artery bypass grafting).&#xD;
&#xD;
         18. Females of childbearing potential who have had unprotected sexual intercourse within&#xD;
             30 days before study entry and who do not agree to use a highly effective method of&#xD;
             contraception (eg, total abstinence, an intrauterine device, a double-barrier method&#xD;
             [such as condom plus diaphragm with spermicide], a progesterone only contraceptive&#xD;
             implant/injection, or have a vasectomized partner with confirmed azoospermia)&#xD;
             throughout the entire study period and for 30 days after study drug discontinuation.&#xD;
             If currently abstinent, the subject must agree to use a double barrier method as&#xD;
             described above if she becomes sexually active during the study period or for 30 days&#xD;
             after study drug discontinuation. All females will be considered to be of childbearing&#xD;
             potential unless they are postmenopausal (at least 12 months consecutive amenorrhea in&#xD;
             the appropriate age group and without other known or suspected cause) or have been&#xD;
             sterilized surgically (ie, bilateral tubal ligation, hysterectomy, or bilateral&#xD;
             oophorectomy) at least 1 month before dosing.&#xD;
&#xD;
         19. Females who are lactating or pregnant at Screening or Baseline (as documented by a&#xD;
             positive serum beta-human chorionic gonadotropin [B-hCG] test with a minimum&#xD;
             sensitivity 25 IU/L or equivalent units of B-hCG). A separate baseline assessment is&#xD;
             required if a negative screening pregnancy test was obtained more than 72 hours before&#xD;
             the first dose of study drug.&#xD;
&#xD;
         20. Post liver transplant subjects.&#xD;
&#xD;
         21. Any subject who has previously received avatrombopag.&#xD;
&#xD;
         22. Hypersensitivity to avatrombopag maleate or any of its excipients.&#xD;
&#xD;
         23. Hemoglobin levels less than or equal to 8.0 or greater than or equal to 16.0 g/dL at&#xD;
             Screening.&#xD;
&#xD;
         24. White blood cell count less than or equal to 1.5 x 10^9/L or greater than or equal to&#xD;
             15.0 x 10^9/L at Screening.&#xD;
&#xD;
         25. Serum sodium level less than or equal to 130 milliequivalents/L at Screening.&#xD;
&#xD;
         26. Current malignancy including solid tumors and hematologic malignancies (except HCC).&#xD;
&#xD;
         27. Any history of a medical condition or a concomitant medical condition that, in the&#xD;
             opinion of the investigator(s), would compromise the subject's ability to safely&#xD;
             complete the study.&#xD;
&#xD;
         28. Currently enrolled in another clinical trial or used any investigational drug or&#xD;
             device within 30 days of Screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iizuka</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kitakyushu</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kure</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sagamihara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ikeda</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Minato-Ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yamanashi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <results_first_submitted>December 4, 2017</results_first_submitted>
  <results_first_submitted_qc>October 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 28, 2019</results_first_posted>
  <last_update_submitted>October 17, 2018</last_update_submitted>
  <last_update_submitted_qc>October 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thrombocytopenia</keyword>
  <keyword>Chronic Liver Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Thrombocytopenia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 56 participants were screened to enter into the study. Of these, 17 participants were screening failures, and 39 were randomized into the study. Of the 17 screening failures, 14 participants failed to meet the inclusion/exclusion criteria, 1 participant withdrew consent, and 2 participants were excluded for scheduling conflicts.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo (60 mg)</title>
          <description>Participants took 60 milligrams (mg) placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="P2">
          <title>Avatrombopag (20 mg)</title>
          <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="P3">
          <title>Avatrombopag (40 mg)</title>
          <description>Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="P4">
          <title>Avatrombopag (60 mg)</title>
          <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 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="11"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS): The FAS was the group of randomized participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo (60 mg)</title>
          <description>Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="B2">
          <title>Avatrombopag (20 mg)</title>
          <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="B3">
          <title>Avatrombopag (40 mg)</title>
          <description>Avatrombopag (40 mg), Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="B4">
          <title>Avatrombopag (60 mg)</title>
          <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="B5">
          <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="11"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="11"/>
            <count group_id="B4" value="10"/>
            <count group_id="B5" value="39"/>
          </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="71.1" spread="8.49"/>
                    <measurement group_id="B2" value="64.6" spread="8.42"/>
                    <measurement group_id="B3" value="64.6" spread="9.59"/>
                    <measurement group_id="B4" value="62.1" spread="7.32"/>
                    <measurement group_id="B5" value="65.8" spread="8.92"/>
                  </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="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4</title>
        <description>Responders were defined as participants whose platelet count was greater than or equal to 50×10^9/liter (L) and change from baseline was at least 20×10^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.</description>
        <time_frame>Baseline and Visit 4 (Day 10)</time_frame>
        <population>Full Analysis Set (FAS) included all randomized participants who received at least one dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (60 mg)</title>
            <description>Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag (20 mg)</title>
            <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag (40 mg)</title>
            <description>Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag (60 mg)</title>
            <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4</title>
          <description>Responders were defined as participants whose platelet count was greater than or equal to 50×10^9/liter (L) and change from baseline was at least 20×10^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.</description>
          <population>Full Analysis Set (FAS) included all randomized participants who received at least one dose of study drug.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" lower_limit="0.2" upper_limit="41.3"/>
                    <measurement group_id="O2" value="28.6" lower_limit="3.7" upper_limit="71.0"/>
                    <measurement group_id="O3" value="63.6" lower_limit="30.8" upper_limit="89.1"/>
                    <measurement group_id="O4" value="40.0" lower_limit="12.2" upper_limit="73.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.146</p_value>
            <method>Shirley-Williams test</method>
            <method_desc>P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.</method_desc>
            <param_type>Difference of responder rate vs. placebo</param_type>
            <param_value>19.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.1</ci_lower_limit>
            <ci_upper_limit>57.0</ci_upper_limit>
            <estimate_desc>Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Shirley-Williams test</method>
            <method_desc>P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.</method_desc>
            <param_type>Difference of responder rate vs. placebo</param_type>
            <param_value>54.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>21.4</ci_lower_limit>
            <ci_upper_limit>87.7</ci_upper_limit>
            <estimate_desc>Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.024</p_value>
            <method>Shirley-Williams test</method>
            <method_desc>P-value is based on Shirley-Williams test at a one-sided significance level of α = 0.025.</method_desc>
            <param_type>Difference of responder rate vs. placebo</param_type>
            <param_value>30.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.9</ci_lower_limit>
            <ci_upper_limit>65.7</ci_upper_limit>
            <estimate_desc>Difference of responder rate vs. placebo = responder rate for avatrombopag - responder rate for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit</title>
        <description>Responders were defined as the participants whose platelet count greater than or equal to 50 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.</description>
        <time_frame>Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (60 mg)</title>
            <description>Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag (20 mg)</title>
            <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag (40 mg)</title>
            <description>Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag (60 mg)</title>
            <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit</title>
          <description>Responders were defined as the participants whose platelet count greater than or equal to 50 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.</description>
          <population>FAS</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3 (Day 4 or Day 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O2" value="14.3" lower_limit="0.4" upper_limit="57.9"/>
                    <measurement group_id="O3" value="27.3" lower_limit="6.0" upper_limit="61.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" lower_limit="0.2" upper_limit="41.3"/>
                    <measurement group_id="O2" value="71.4" lower_limit="29.0" upper_limit="96.3"/>
                    <measurement group_id="O3" value="81.8" lower_limit="48.2" upper_limit="97.7"/>
                    <measurement group_id="O4" value="50.0" lower_limit="18.7" upper_limit="81.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (Day 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3" lower_limit="6.0" upper_limit="61.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="54.5" lower_limit="23.4" upper_limit="83.3"/>
                    <measurement group_id="O4" value="20.0" lower_limit="2.5" upper_limit="55.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (Day 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" lower_limit="2.3" upper_limit="51.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="9.1" lower_limit="0.2" upper_limit="41.3"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 3 (Day 4 or Day 5)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.388</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.6</ci_lower_limit>
            <ci_upper_limit>40.2</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 3 (Day 4 or Day 5)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.214</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>27.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.0</ci_lower_limit>
            <ci_upper_limit>53.6</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 4 (Day 10)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.012</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>62.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.8</ci_lower_limit>
            <ci_upper_limit>99.9</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 4 (Day 10)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>72.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>44.3</ci_lower_limit>
            <ci_upper_limit>100.0</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 4 (Day 10)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.063</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>40.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.6</ci_lower_limit>
            <ci_upper_limit>76.2</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 5 (Day 17)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.245</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>-27.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-53.6</ci_lower_limit>
            <ci_upper_limit>-1.0</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 5 (Day 17)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.386</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>27.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.2</ci_lower_limit>
            <ci_upper_limit>66.8</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 5 (Day 17)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1.000</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>-7.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-43.4</ci_lower_limit>
            <ci_upper_limit>28.9</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 6 (Day 35)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.496</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>-18.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.0</ci_lower_limit>
            <ci_upper_limit>4.6</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 6 (Day 35)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>1.000</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>-9.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.5</ci_lower_limit>
            <ci_upper_limit>19.3</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 6 (Day 35)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.476</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α = 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>-18.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-41.0</ci_lower_limit>
            <ci_upper_limit>4.6</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit</title>
        <description>Responders were defined as the participants whose platelet count greater than or equal to 75 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.</description>
        <time_frame>Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (60 mg)</title>
            <description>Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag (20 mg)</title>
            <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag (40 mg)</title>
            <description>Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag (60 mg)</title>
            <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit</title>
          <description>Responders were defined as the participants whose platelet count greater than or equal to 75 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.</description>
          <population>FAS</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3 (Day 4 or Day 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="63.6" lower_limit="30.8" upper_limit="89.1"/>
                    <measurement group_id="O4" value="30.0" lower_limit="6.7" upper_limit="65.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (Day 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O4" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (Day 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 4 (Day 10)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.003</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>63.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.2</ci_lower_limit>
            <ci_upper_limit>92.1</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 4 (Day 10)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.090</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>30.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.6</ci_lower_limit>
            <ci_upper_limit>58.4</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 5 (Day 17)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.476</p_value>
            <p_value_desc>P-value is based on Fisher's exact test at a two-sided significance level of α= 0.05.</p_value_desc>
            <method>Fisher Exact</method>
            <param_type>Difference of proportion vs. placebo</param_type>
            <param_value>10.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.6</ci_lower_limit>
            <ci_upper_limit>28.6</ci_upper_limit>
            <estimate_desc>Difference of proportion vs. placebo = proportion of responders for avatrombopag - proportion of responders for placebo; 95% CI is calculated based on normal approximation.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit</title>
        <description>Responders were defined as the participants whose platelet count greater than or equal to 150 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.</description>
        <time_frame>Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (60 mg)</title>
            <description>Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag (20 mg)</title>
            <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag (40 mg)</title>
            <description>Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag (60 mg)</title>
            <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit</title>
          <description>Responders were defined as the participants whose platelet count greater than or equal to 150 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.</description>
          <population>FAS</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3 (Day 4 or Day 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (Day 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (Day 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit</title>
        <description>Responders were defined as the participants whose platelet count greater than or equal to 200 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.</description>
        <time_frame>Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (60 mg)</title>
            <description>Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag (20 mg)</title>
            <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag (40 mg)</title>
            <description>Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag (60 mg)</title>
            <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit</title>
          <description>Responders were defined as the participants whose platelet count greater than or equal to 200 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.</description>
          <population>FAS</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3 (Day 4 or Day 5)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (Day 17)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (Day 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Platelet Count and Change From Baseline in Platelet Count by Visit</title>
        <time_frame>Baseline, Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)</time_frame>
        <population>FAS</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo (60 mg)</title>
            <description>Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag (20 mg)</title>
            <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag (40 mg)</title>
            <description>Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag (60 mg)</title>
            <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Platelet Count and Change From Baseline in Platelet Count by Visit</title>
          <population>FAS</population>
          <units>Number of platelets x 10^9/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 2 (Baseline) Platelet count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.59" spread="7.024"/>
                    <measurement group_id="O2" value="40.57" spread="5.556"/>
                    <measurement group_id="O3" value="41.23" spread="5.159"/>
                    <measurement group_id="O4" value="28.85" spread="7.568"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Day 4 or Day 5) Platelet count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.27" spread="8.344"/>
                    <measurement group_id="O2" value="44.71" spread="6.102"/>
                    <measurement group_id="O3" value="46.09" spread="8.860"/>
                    <measurement group_id="O4" value="32.70" spread="9.967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Day 4 or Day 5) Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="2.848"/>
                    <measurement group_id="O2" value="4.14" spread="7.099"/>
                    <measurement group_id="O3" value="4.86" spread="6.569"/>
                    <measurement group_id="O4" value="3.85" spread="6.223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 10) Platelet count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.91" spread="10.568"/>
                    <measurement group_id="O2" value="53.29" spread="5.678"/>
                    <measurement group_id="O3" value="79.36" spread="24.800"/>
                    <measurement group_id="O4" value="55.90" spread="22.507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (Day 10) Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.32" spread="7.163"/>
                    <measurement group_id="O2" value="12.71" spread="9.486"/>
                    <measurement group_id="O3" value="38.14" spread="22.781"/>
                    <measurement group_id="O4" value="27.05" spread="22.700"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (Day 17) Platelet count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.10" spread="9.916"/>
                    <measurement group_id="O2" value="41.33" spread="4.803"/>
                    <measurement group_id="O3" value="55.73" spread="14.826"/>
                    <measurement group_id="O4" value="41.80" spread="16.578"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (Day 17) Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.40" spread="5.243"/>
                    <measurement group_id="O2" value="1.75" spread="3.402"/>
                    <measurement group_id="O3" value="14.50" spread="11.874"/>
                    <measurement group_id="O4" value="12.95" spread="12.857"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (Day 35) Platelet count</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.50" spread="10.845"/>
                    <measurement group_id="O2" value="39.67" spread="5.574"/>
                    <measurement group_id="O3" value="41.36" spread="8.262"/>
                    <measurement group_id="O4" value="31.44" spread="8.353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (Day 35) Change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" spread="4.614"/>
                    <measurement group_id="O2" value="0.08" spread="1.686"/>
                    <measurement group_id="O3" value="0.14" spread="8.382"/>
                    <measurement group_id="O4" value="2.33" spread="4.265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 3 (Day 4 or Day 5)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.296</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 3 (Day 4 or Day 5)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.070</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 3 (Day 4 or Day 5)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.138</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 4 (Day 10)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.012</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 4 (Day 10)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 4 (Day 10)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 5 (Day 17)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.624</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 5 (Day 17)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.009</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 5 (Day 17)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.010</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Visit 6 (Day 35)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.154</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Visit 6 (Day 35)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.216</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Visit 6 (Day 35)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.901</p_value>
            <p_value_desc>P-value is based on Wilcoxon rank sum test at a two-sided significance level of α = 0.05 for each avatrombopag treatment group vs. placebo.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>Safety assessments consisted of monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms; physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. A treatment-emergent adverse event (TEAE) was defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. For each category, a participant with two or more adverse events in that category was counted only once. Treatment-related TEAEs were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing causality.</description>
        <time_frame>From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months</time_frame>
        <population>Safety Analysis Set included all participants who received at least one dose of study drug and had at least one safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag 20-mg</title>
            <description>20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag 40-mg</title>
            <description>40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag 60-mg</title>
            <description>60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>Safety assessments consisted of monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms; physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. A treatment-emergent adverse event (TEAE) was defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. For each category, a participant with two or more adverse events in that category was counted only once. Treatment-related TEAEs were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing causality.</description>
          <population>Safety Analysis Set included all participants who received at least one dose of study drug and had at least one safety assessment.</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="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious TEAEs</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs leading to study drug dose adjustment</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs leading to study drug withdrawal</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs leading to study drug dose reduction</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TEAEs leading to study drug dose interruption</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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology</title>
        <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
        <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag 20-mg</title>
            <description>20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag 40-mg</title>
            <description>40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag 60-mg</title>
            <description>60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology</title>
          <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline phosphatase (ALP)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase (ALT)</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gamma-glutamyl transferase (γ-GTP)</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium</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_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Triglycerides</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase (AST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Clinically Significant Findings in Laboratory Values for Serum</title>
        <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
        <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag 20-mg</title>
            <description>20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag 40-mg</title>
            <description>40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag 60-mg</title>
            <description>60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Findings in Laboratory Values for Serum</title>
          <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Clinically Significant Findings in Laboratory Values for Urinalysis</title>
        <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
        <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag 20-mg</title>
            <description>20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag 40-mg</title>
            <description>40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag 60-mg</title>
            <description>60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Findings in Laboratory Values for Urinalysis</title>
          <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values</title>
        <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
        <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag 20-mg</title>
            <description>20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag 40-mg</title>
            <description>40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag 60-mg</title>
            <description>60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values</title>
          <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Markedly Abnormal Electrocardiographs</title>
        <time_frame>From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)</time_frame>
        <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Placebo (3 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O2">
            <title>Avatrombopag 20-mg</title>
            <description>20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O3">
            <title>Avatrombopag 40-mg</title>
            <description>40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) received after a meal once daily for 5 days</description>
          </group>
          <group group_id="O4">
            <title>Avatrombopag 60-mg</title>
            <description>60 mg avatrombopag (3 x 20 mg tablets) received after a meal once daily for 5 days</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Markedly Abnormal Electrocardiographs</title>
          <population>The safety analysis set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.</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="11"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="11"/>
                <count group_id="O4" value="10"/>
              </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months.</time_frame>
      <desc>Treatment-emergent adverse events and serious adverse events are reported. All adverse events were graded on a 5-point scale according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The safety analysis set was analyzed and included all participants who received at least one dose of study drug and had at least one post dose safety assessment. This set was analyzed &quot;as treated.&quot;</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo (60 mg)</title>
          <description>Participants took 60 mg placebo (3 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="E2">
          <title>Avatrombopag (20 mg)</title>
          <description>Participants took 20 mg avatrombopag (1 x 20 mg avatrombopag tablet and 2 x 20 mg matching placebo tablets) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="E3">
          <title>Avatrombopag (40 mg)</title>
          <description>Participants took 40 mg avatrombopag (2 x 20 mg avatrombopag tablets and 1 x 20 mg matching placebo tablet) orally after a meal, once daily for 5 days.</description>
        </group>
        <group group_id="E4">
          <title>Avatrombopag (60 mg)</title>
          <description>Participants took 60 mg avatrombopag (3 x 20 mg avatrombopag tablets) orally, after a meal, once daily for 5 days.</description>
        </group>
      </group_list>
      <serious_events>
        <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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctival Haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Puncture Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Thirst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vessel Puncture Site Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acute Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post Embolisation Syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Post Procedural Complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Neck Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </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="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Eczema Asteatotic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemorrhage Subcutaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rosacea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </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>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eisai Medical Services</name_or_title>
      <organization>Eisai Inc.</organization>
      <phone>1-888-274-2378</phone>
      <email>esi_medinfo@eisai.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/NCT02227693
org study id: E5501-J081-204
nct id: NCT02227693
lead sponsor: 
has dmc: No
This is a phase 2, randomized, double-blind, placebo-controlled, parallel group study using
      avatrombopag for Japanese subjects with thrombocytopenia associated with chronic liver
      disease. This study will assess the effect of avatrombopag on platelet counts in Japanese
      subjects. Subjects will be enrolled into 2 cohorts according to the mean platelet count
      measured at Screening and Baseline. Within the lower baseline platelet count cohort (less
      than 40 x 10^9/L), subjects will be randomized in a 1:1:1:3 ratio to receive placebo, 20 mg
      avatrombopag, 40 mg avatrombopag, or 60 mg avatrombopag for 5 days. Within the higher
      baseline platelet count cohort (from 40 to less than 50 x 10^9/L), subjects will be
      randomized in a 2:1:2 ratio to receive placebo, 20 mg avatrombopag, or 40 mg avatrombopag for
      5 days.
This study will consist of Prerandomization Phase and Randomization Phase. The
      Prerandomization Phase includes a Screening Period (Day -28 to Day -1) and a Baseline Period
      (Day 1). During the Prerandomization Phase, participants will be divided into two cohorts
      based on the platelet count: Low Platelet Count Cohort and High Platelet Count Cohort.
      Participants in Low Platelet Count Cohort will be randomized to receive one of the four
      treatments: Placebo, Avatrombopag 20 mg, Avatrombopag 40 mg, or Avatrombopag 60 mg.
      Participants in High Platelet Count Cohort will be randomized to receive one of the three
      treatments: Placebo, Avatrombopag 20 mg, or Avatrombopag 40 mg.

      The Randomization Phase includes the Treatment Period and the Follow-up Period. The Follow-up
      Period comprises 3 visits: Visit 4 (5 to 8 days after last dose of study drug [Study Day 10
      to 13]), Visit 5 (12 to 15 days after last dose of study drug [Study Day 17 to 20]), and 30
      days after receiving the last dose of study drug.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L and at Least 20 x 10^9/L Increase From Baseline at Visit 4
time frame: Baseline and Visit 4 (Day 10)
description: Responders were defined as participants whose platelet count was greater than or equal to 50×10^9/liter (L) and change from baseline was at least 20×10^9/L at Visit 4. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% confidence interval (CI) is calculated by Clopper and Pearson method.
measure: Percentage of Participants With Platelet Count Greater Than or Equal to 50 x 10^9/L at Each Visit
time frame: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
description: Responders were defined as the participants whose platelet count greater than or equal to 50 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.
measure: Percentage of Participants With Platelet Count Greater Than or Equal to 75 x 10^9/L at Each Visit
time frame: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
description: Responders were defined as the participants whose platelet count greater than or equal to 75 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis. Two-sided 95% CI is calculated by Clopper and Pearson method.
measure: Percentage of Participants With Platelet Count Greater Than or Equal to 150 x 10^9/L At Each Visit
time frame: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
description: Responders were defined as the participants whose platelet count greater than or equal to 150 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.
measure: Percentage of Participants With Platelet Count Greater Than or Equal to 200 x 10^9/L At Each Visit
time frame: Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
description: Responders were defined as the participants whose platelet count greater than or equal to 200 x 10^9/L by visit. Participants receiving a platelet transfusion prior to the platelet count assessment at Visit 4 were considered as non-responders in the analysis.
measure: Platelet Count and Change From Baseline in Platelet Count by Visit
time frame: Baseline, Visit 3 (Day 4 or 5), Visit 4 (Day 10), Visit 5 (Day 17) and Visit 6 (Day 35)
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From the date of first dose of study drug up to 30 days after the last dose of the study drug, up to approximately 10 months
description: Safety assessments consisted of monitoring and recording all AEs and SAEs, regular monitoring of hematology, blood chemistry, and urine values; periodic measurement of vital signs and electrocardiograms; physical examinations; and Doppler sonography. AE severity was graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = Severe, Grade 4 = Life-threatening, and Grade 5 = Death related to the AE. All AEs graded as 4 or 5 were considered to be serious. A treatment-emergent adverse event (TEAE) was defined as an AE that started on or after the date of first dose of study drug, up to 30 days after the last dose of study drug. For each category, a participant with two or more adverse events in that category was counted only once. Treatment-related TEAEs were considered by the investigator to be possibly or probably related to study drug or TEAEs with a missing causality.
measure: Number of Participants With Treatment-emergent Markedly Abnormal Laboratory Value (TEMAV) for Haematology
time frame: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
measure: Number of Participants With Clinically Significant Findings in Laboratory Values for Serum
time frame: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
measure: Number of Participants With Clinically Significant Findings in Laboratory Values for Urinalysis
time frame: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
time frame: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
measure: Number of Participants With Markedly Abnormal Electrocardiographs
time frame: From the date of Screening until the date of last dose of study drug plus 30 days (Approximately 10 months)
arm group label: avatrombopag 20-mg
arm group type: Experimental
description: 20 mg avatrombopag (1 x 20 mg tablet and 2 x 20 mg matching placebo tablets) once daily on Days 1 through 5
arm group label: avatrombopag 40-mg
arm group type: Experimental
description: 40 mg avatrombopag (2 x 20 mg tablets and 1 x 20 mg matching placebo tablet) once daily on Days 1 through 5
arm group label: avatrombopag 60-mg
arm group type: Experimental
description: 60 mg avatrombopag (3 x 20 mg tablets) once daily on Days 1 through 5
arm group label: placebo l
arm group type: Placebo Comparator
description: Placebo (3 x 20-mg matching placebo tablets) once daily on Days 1 through 5
intervention type: Drug
intervention name: avatrombopag
description: E5501 (avatrombopag) 20-mg tablets
arm group label: avatrombopag 20-mg
arm group label: avatrombopag 40-mg
arm group label: avatrombopag 60-mg
intervention type: Drug
intervention name: Placebo
description: Placebo matching 20-mg tablets
arm group label: placebo l
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Thrombocytopenia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 