<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/NCT01702363</url>
  </required_header>
  <id_info>
    <org_study_id>115361</org_study_id>
    <nct_id>NCT01702363</nct_id>
  </id_info>
  <brief_title>Long-term Safety Study for GSK573719 in Japanese</brief_title>
  <acronym>AC4115361</acronym>
  <official_title>A 52-week, Multi-centre, Open-label Study to Evaluate the Safety and Tolerability of GSK573719 125 mcg Once-daily Via Novel Dry Powder Inhaler (nDPI) in Japanese Subjects With Chronic Obstructive Pulmonary Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the safety and tolerability of GSK573719&#xD;
      Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) treatment guidelines recommend an incremental&#xD;
      approach to pharmacological treatment as the disease state worsens, involving the use of&#xD;
      combinations of drug classes with different or complementary mechanisms of action [Celli,&#xD;
      2004, GOLD 2009]. As disease progresses from mild to moderate, regular treatment with one or&#xD;
      more long-acting bronchodilators is recommended. Inhaled bronchodilators, including beta2&#xD;
      agonists and anticholinergics are included with inhaled corticosteroids (ICS) therapy and are&#xD;
      mainstays of therapy in patients diagnosed with COPD. Since GSK573719 Inhalation Powder is&#xD;
      expected to be used for chronic management of COPD as long-acting muscarinic antagonist&#xD;
      (LAMA), this study is intended to evaluate the safety and tolerability of long-term&#xD;
      administration of GSK573719 Inhalation Powder 125 mcg in Japanese patients with COPD at doses&#xD;
      possibly used to be in Japan.&#xD;
&#xD;
      In this study, patient safety will also be monitored by evaluating pulmonary function and&#xD;
      clinical symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period</measure>
    <time_frame>From the first dose of study medication up to 52 weeks</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period</measure>
    <time_frame>From the first dose of study medication up to 52 weeks</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</measure>
    <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit</time_frame>
    <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</measure>
    <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
    <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</measure>
    <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
    <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</measure>
    <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
    <description>Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD</measure>
    <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
    <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD</measure>
    <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
    <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</measure>
    <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
    <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From BL in Blood Pressure Throughout the Treatment Period</measure>
    <time_frame>BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit</time_frame>
    <description>Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From BL in Heart Rate Throughout the Treatment Period</measure>
    <time_frame>BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit</time_frame>
    <description>Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points</measure>
    <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit</time_frame>
    <description>A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) &gt;500 milliseconds (msec) or an uncorrected QT interval &gt;600 msec, for participants with Bundle Branch Block QTc &gt;530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>GSK573719</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>125mcg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GSK573719</intervention_name>
    <description>GSK573719 inhalation powder inhaled orally once daily for 52 weeks.</description>
    <arm_group_label>GSK573719</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatient.&#xD;
&#xD;
          -  A signed and dated written informed consent prior to study participation.&#xD;
&#xD;
          -  Japanese subjects 40 years of age or older at Visit 1.&#xD;
&#xD;
          -  Male or female subjects. A female is eligible if she is of: Non-child bearing&#xD;
             potential or Child bearing potential agrees to one of the contraceptive methods.&#xD;
&#xD;
          -  Subjects with a clinical history of COPD in accordance with the definition by COPD&#xD;
             domestic guideline.&#xD;
&#xD;
          -  Current or former cigarette smokers with a history of cigarette smoking of &gt;=10&#xD;
             pack-years at Visit 1.&#xD;
&#xD;
          -  Subject with a measured post-salbutamol forced expiratory volume/forced vital capacity&#xD;
             (FEV1/FVC) ratio of &lt;70% and Subjects with a measured post-salbutamol FEV1 &lt;80% of&#xD;
             predicted normal values.&#xD;
&#xD;
        Exclusion Criteria (Visit 1):&#xD;
&#xD;
          -  Women who are pregnant or lactating or are planning on becoming pregnant during the&#xD;
             study.&#xD;
&#xD;
          -  A current diagnosis of asthma.&#xD;
&#xD;
          -  Known respiratory disorders other than COPD.&#xD;
&#xD;
          -  Subjects with historical or current evidence of clinically significant abnormalities&#xD;
             that are uncontrolled.&#xD;
&#xD;
          -  A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically&#xD;
             significant abnormalities not believed to be due to the presence of COPD.&#xD;
&#xD;
          -  Allergy or hypersensitivity to muscarinic, beta2-agonist, lactose/milk protein or&#xD;
             magnesium stearate or a condition that contraindicates participation.&#xD;
&#xD;
          -  Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.&#xD;
&#xD;
          -  Subjects with lung volume reduction surgery within the 12 months prior to Screening&#xD;
             (Visit 1).&#xD;
&#xD;
          -  An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1.&#xD;
&#xD;
          -  Significantly abnormal finding from clinical chemistry or hematology, tests at Visit&#xD;
             1.&#xD;
&#xD;
          -  Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for&#xD;
             greater than 12 hours a day.&#xD;
&#xD;
          -  Regular use (prescribed every day, not for as-needed use) of short-acting&#xD;
             bronchodilators (e.g., salbutamol) via nebulized therapy.&#xD;
&#xD;
          -  Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks&#xD;
             prior to Visit 1.&#xD;
&#xD;
          -  A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1.&#xD;
&#xD;
          -  Affiliation with Investigator Site.&#xD;
&#xD;
          -  Previous use of GSK573719, the GSK573719/GW642444 combination.&#xD;
&#xD;
          -  Use of any other investigational medication within 30 days or 5 drug half-lives&#xD;
             (whichever is longer).&#xD;
&#xD;
        Exclusion Criteria (Visit 2):&#xD;
&#xD;
        - COPD Exacerbation during run-in period: Subject must not have experienced a COPD&#xD;
        exacerbation or a lower respiratory tract infection during run-in or at Visit 2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1347</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gunma</city>
        <zip>371-0048</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hokkaido</city>
        <zip>080-0805</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hyogo</city>
        <zip>670-0849</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>300-0053</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ibaraki</city>
        <zip>302-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ishikawa</city>
        <zip>920-8610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kanagawa</city>
        <zip>239-0821</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kyoto</city>
        <zip>601-1495</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miyagi</city>
        <zip>983-0824</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nagano</city>
        <zip>391-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oita</city>
        <zip>870-0921</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oita</city>
        <zip>876-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>530-0001</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Osaka</city>
        <zip>589-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Shizuoka</city>
        <zip>436-0022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>103-0027</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>153-8934</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <zip>192-0903</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Yamanashi</city>
        <zip>400-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <results_first_submitted>July 17, 2014</results_first_submitted>
  <results_first_submitted_qc>July 17, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 8, 2014</results_first_posted>
  <last_update_submitted>November 18, 2016</last_update_submitted>
  <last_update_submitted_qc>November 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Obstructive Pulmonary Disease (COPD), GSK573719, Pharmacogenetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>115361</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115361</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115361</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115361</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115361</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115361</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>115361</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 131 Japanese participants with chronic obstructive pulmonary disease (COPD) who met the eligibility criteria were registered and administration of investigational product was started</recruitment_details>
      <pre_assignment_details>Participants entered a 7- to 14-day Run-in Period followed by a 52-week Treatment Period. Follow-up was conducted by a phone call approximately 1 week following the completion of treatment or withdrawal from the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>UMEC 125 µg QD</title>
          <description>Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>UMEC 125 µg QD</title>
          <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="131"/>
          </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="69.2" spread="7.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Asian - Japanese Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period</title>
        <description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.</description>
        <time_frame>From the first dose of study medication up to 52 weeks</time_frame>
        <population>Intent-to Treat (ITT) Population: All participants who received at least one dose of the study medication. For participants who withdrew from the study, all available data collected until the time of study discontinuation were included in the ITT analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period</title>
          <description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.</description>
          <population>Intent-to Treat (ITT) Population: All participants who received at least one dose of the study medication. For participants who withdrew from the study, all available data collected until the time of study discontinuation were included in the ITT analysis.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period</title>
        <description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).</description>
        <time_frame>From the first dose of study medication up to 52 weeks</time_frame>
        <population>ITT Population</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period</title>
          <description>An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).</description>
          <population>ITT Population</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE, mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE, moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any AE, severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</title>
        <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
        <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</title>
          <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>Percentage of cells in blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Basophils, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="0.462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.68" spread="0.494"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.433"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.391"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.455"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.61" spread="0.516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.460"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.74" spread="3.573"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.61" spread="2.451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.74" spread="3.453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.69" spread="2.903"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.93" spread="4.188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.94" spread="3.715"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.61" spread="3.424"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.81" spread="4.133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.96" spread="7.711"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.53" spread="7.340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.98" spread="7.214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.76" spread="6.840"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.87" spread="6.622"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.58" spread="10.609"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.26" spread="8.001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.12" spread="7.442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.35" spread="1.494"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" spread="1.516"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.39" spread="1.751"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.25" spread="1.539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="1.727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.83" spread="2.264"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.34" spread="1.848"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.38" spread="1.800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.34" spread="7.818"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.93" spread="8.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.26" spread="8.273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.67" spread="7.219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.11" spread="7.107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.04" spread="14.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.16" spread="9.378"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.05" spread="8.565"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</title>
        <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
        <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>MEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</title>
          <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>10^9 cells per Liter (GI/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="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Eosinophils, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.222" spread="0.1808"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.213" spread="0.1426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.218" spread="0.1958"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.215" spread="0.1542"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.233" spread="0.2074"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.189" spread="0.2265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.210" spread="0.1947"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.228" spread="0.2093"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.673" spread="1.1732"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.705" spread="1.1894"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.639" spread="1.2147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.576" spread="1.1978"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.709" spread="1.1155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.657" spread="2.3277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.709" spread="1.4098"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Neutrophils, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.821" spread="1.3405"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228.8" spread="55.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232.1" spread="57.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228.3" spread="53.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="224.6" spread="51.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="229.3" spread="52.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217.3" spread="48.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.9" spread="54.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="227.9" spread="51.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.24" spread="1.594"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.13" spread="1.549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.07" spread="1.544"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.04" spread="1.552"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.23" spread="1.558"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.87" spread="2.456"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.08" spread="1.664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC Count, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.31" spread="1.690"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</title>
        <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
        <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</title>
          <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>Grams per Liter (G/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="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.2" spread="13.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.4" spread="13.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.3" spread="13.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145.6" spread="12.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147.8" spread="13.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoblobin, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134.4" spread="13.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.5" spread="14.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.2" spread="14.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" spread="2.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5" spread="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" spread="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" spread="2.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.6" spread="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.9" spread="3.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.1" spread="3.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.2" spread="3.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Protein, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4" spread="4.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Protein, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.9" spread="4.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Protein, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.8" spread="4.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Protein, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0" spread="4.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Protein, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4" spread="4.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Protein, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.7" spread="4.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Protein, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.6" spread="4.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Protein, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.1" spread="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</title>
        <description>Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
        <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD</title>
          <description>Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>Proportion of red blood cells in blood</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4457" spread="0.03961"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4511" spread="0.04075"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4513" spread="0.03895"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4434" spread="0.03628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4419" spread="0.03726"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4124" spread="0.04371"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4484" spread="0.04108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4384" spread="0.03909"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD</title>
        <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
        <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD</title>
          <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>International Units per Liter (IU/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="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AP, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="233.1" spread="61.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239.2" spread="68.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237.5" spread="63.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232.4" spread="65.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235.1" spread="64.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="258.0" spread="83.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239.4" spread="67.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AP, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237.8" spread="67.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" spread="11.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" spread="9.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.9" spread="10.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1" spread="11.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7" spread="10.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.9" spread="27.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5" spread="13.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" spread="13.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" spread="11.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" spread="8.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2" spread="7.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" spread="11.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.2" spread="8.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7" spread="25.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" spread="10.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.8" spread="11.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124.8" spread="71.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.7" spread="92.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117.3" spread="70.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.8" spread="70.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109.5" spread="60.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.7" spread="147.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.8" spread="82.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.7" spread="75.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.1" spread="38.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1" spread="34.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.5" spread="42.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.0" spread="44.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.2" spread="49.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.5" spread="77.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9" spread="48.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GGT, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.1" spread="53.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD</title>
        <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
        <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD</title>
          <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>Micromoles per Liter (µM/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="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Direct Bilirubin, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.577" spread="2.0172"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.284" spread="1.6699"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.137" spread="1.5508"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.450" spread="1.7323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.389" spread="1.6783"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.192" spread="1.4258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.153" spread="1.5539"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Direct Bilirubin, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.366" spread="1.6464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.305" spread="2.8933"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.664" spread="2.8271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.444" spread="2.8077"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.975" spread="3.4662"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.948" spread="3.0176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.814" spread="3.0861"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.426" spread="2.8930"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Indirect Bilirubin, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.813" spread="3.0358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.881" spread="4.4353"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.948" spread="4.0720"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.582" spread="3.9273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.425" spread="4.7718"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.337" spread="4.3954"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.006" spread="4.3099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.579" spread="4.0337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bilirubin, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.179" spread="4.3896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.1088" spread="15.62560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.5965" spread="16.73127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.1894" spread="15.82538"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2092" spread="15.29351"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.3287" spread="14.54036"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.0277" spread="26.02168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.3789" spread="16.14369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.0072" spread="16.28875"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="347.9353" spread="81.78271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="336.5813" spread="78.06630"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="346.9011" spread="78.45280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="352.6016" spread="81.62589"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343.4836" spread="67.79140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343.3979" spread="96.73417"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="344.4264" spread="78.41134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="343.4734" spread="71.35989"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</title>
        <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
        <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD</title>
          <description>Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>Millimoles per Liter (MMOL/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="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Calcium, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2804" spread="0.09567"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2720" spread="0.09628"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2589" spread="0.10287"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2505" spread="0.09407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2680" spread="0.09580"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1923" spread="0.09281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2556" spread="0.10334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2590" spread="0.09822"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.2" spread="2.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.0" spread="2.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.0" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.2" spread="3.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.1" spread="2.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.1" spread="4.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.0" spread="3.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.1" spread="2.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9980" spread="1.55438"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3127" spread="1.91203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2735" spread="1.75968"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6047" spread="2.23873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3957" spread="1.88553"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9721" spread="2.28881"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3364" spread="1.83801"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4643" spread="1.93661"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2/HCO3, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.7" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2/HCO3, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.2" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2/HCO3, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2/HCO3, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.6" spread="2.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2/HCO3, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="2.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2/HCO3, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.9" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2/HCO3, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.0" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CO2/HCO3, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" spread="0.322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.34" spread="0.309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.32" spread="0.359"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.26" spread="0.345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.23" spread="0.325"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.21" spread="0.261"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.31" spread="0.355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.23" spread="0.317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.5" spread="1.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.6" spread="1.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142.0" spread="1.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.6" spread="1.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.0" spread="1.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140.8" spread="2.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.9" spread="2.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.0" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic Phosphorus , BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9707" spread="0.14747"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic Phosphorus, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9731" spread="0.14204"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic Phosphorus, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9895" spread="0.14258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic Phosphorus, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9942" spread="0.14571"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic Phosphorus, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9888" spread="0.15944"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic Phosphorus, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9687" spread="0.18388"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic Phosphorus, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9853" spread="0.14531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Inorganic Phosphorus, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9864" spread="0.16187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, BL (Week -2), n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2945" spread="1.72055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4556" spread="1.50863"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4072" spread="1.44057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4386" spread="1.73080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1788" spread="1.37133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, WD Visit, n=15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2546" spread="2.28218"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, Week 24/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4551" spread="1.48499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urea/BUN, Week 52/WD, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3068" spread="1.53642"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From BL in Blood Pressure Throughout the Treatment Period</title>
        <description>Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.</description>
        <time_frame>BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From BL in Blood Pressure Throughout the Treatment Period</title>
          <description>Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>millimeters of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP, Week 4, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="12.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 8, n=127</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="13.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="15.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="15.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="16.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="14.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, WD Visit, n=17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.4" spread="20.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 24/WD, n=129</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="16.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP, Week 52/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="15.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 4, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="9.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 8, n=127</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="10.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="10.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" spread="9.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="11.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="9.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, WD Visit, n=17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="11.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 24/WD, n=129</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="10.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP, Week 52/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="9.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From BL in Heart Rate Throughout the Treatment Period</title>
        <description>Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.</description>
        <time_frame>BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters or at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From BL in Heart Rate Throughout the Treatment Period</title>
          <description>Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters or at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="9.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, n=127</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="11.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="9.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="9.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="10.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="9.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WD Visit, n=17</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" spread="30.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24/WD, n=129</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="14.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52/WD, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="14.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points</title>
        <description>A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) &gt;500 milliseconds (msec) or an uncorrected QT interval &gt;600 msec, for participants with Bundle Branch Block QTc &gt;530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
        <time_frame>BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit</time_frame>
        <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
        <group_list>
          <group group_id="O1">
            <title>UMEC 125 µg QD</title>
            <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points</title>
          <description>A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) &gt;500 milliseconds (msec) or an uncorrected QT interval &gt;600 msec, for participants with Bundle Branch Block QTc &gt;530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).</description>
          <population>ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>BL (Week -2) Abnormal NCS, n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BL (Week -2), Abnormal CS, n=131</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Abnormal NCS, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, Abnormal CS, n=126</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, Abnormal NCS, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24, Abnormal CS, n=121</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, Abnormal NCS, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 36, Abnormal CS, n=114</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, Abnormal NCS, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52, Abnormal CS, n=111</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WD Visit, Abnormal NCS, n=16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WD Visit, Abnormal CS, n=16</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24/WD, Abnormal NCS, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 24/WD, Abnormal CS, n=128</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52/WD, Abnormal NCS, n=127</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52/WD, Abnormal CS, n=127</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).</time_frame>
      <desc>SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>UMEC 125 µg QD</title>
          <description>Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fractured ischium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Pubis fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Colon cancer stage 0</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Gastric cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</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="71" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="42" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="131"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="131"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </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/NCT01702363
org study id: 115361
nct id: NCT01702363
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the safety and tolerability of GSK573719
      Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.
Chronic Obstructive Pulmonary Disease (COPD) treatment guidelines recommend an incremental
      approach to pharmacological treatment as the disease state worsens, involving the use of
      combinations of drug classes with different or complementary mechanisms of action [Celli,
      2004, GOLD 2009]. As disease progresses from mild to moderate, regular treatment with one or
      more long-acting bronchodilators is recommended. Inhaled bronchodilators, including beta2
      agonists and anticholinergics are included with inhaled corticosteroids (ICS) therapy and are
      mainstays of therapy in patients diagnosed with COPD. Since GSK573719 Inhalation Powder is
      expected to be used for chronic management of COPD as long-acting muscarinic antagonist
      (LAMA), this study is intended to evaluate the safety and tolerability of long-term
      administration of GSK573719 Inhalation Powder 125 mcg in Japanese patients with COPD at doses
      possibly used to be in Japan.

      In this study, patient safety will also be monitored by evaluating pulmonary function and
      clinical symptoms.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period
time frame: From the first dose of study medication up to 52 weeks
description: An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.
measure: Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period
time frame: From the first dose of study medication up to 52 weeks
description: An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).
measure: Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
description: Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
measure: Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
description: Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
measure: Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
description: Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
measure: Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
description: Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
measure: Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
description: Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
measure: Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
description: Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
measure: Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
description: Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
measure: Change From BL in Blood Pressure Throughout the Treatment Period
time frame: BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
description: Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
measure: Change From BL in Heart Rate Throughout the Treatment Period
time frame: BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
description: Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
measure: Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
time frame: BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
description: A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) >500 milliseconds (msec) or an uncorrected QT interval >600 msec, for participants with Bundle Branch Block QTc >530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
arm group label: GSK573719
arm group type: Experimental
description: 125mcg
intervention type: Drug
intervention name: GSK573719
description: GSK573719 inhalation powder inhaled orally once daily for 52 weeks.
arm group label: GSK573719
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Japan
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
study doc: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 