<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/NCT03242759</url>
  </required_header>
  <id_info>
    <org_study_id>1199-0303</org_study_id>
    <nct_id>NCT03242759</nct_id>
  </id_info>
  <brief_title>Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan</brief_title>
  <official_title>Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a non-interventional, multi-center study to collect data from patients with&#xD;
      idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried&#xD;
      out at 10 medical centers, the expert centers where IPF patients are mainly managed in&#xD;
      Taiwan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2017</start_date>
  <completion_date type="Actual">February 18, 2020</completion_date>
  <primary_completion_date type="Actual">February 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52</measure>
    <time_frame>At baseline and Week 52.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100</measure>
    <time_frame>At baseline and Week 100.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52</measure>
    <time_frame>At baseline and Week 52.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100</measure>
    <time_frame>At baseline and Week 100.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52</measure>
    <time_frame>At baseline and Week 52.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100</measure>
    <time_frame>At baseline and Week 100.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52</measure>
    <time_frame>At baseline and Week 52.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100</measure>
    <time_frame>At baseline and Week 100.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52</measure>
    <time_frame>At baseline and Week 52.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100</measure>
    <time_frame>At baseline and Week 100.</time_frame>
    <description>Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis</measure>
    <time_frame>From baseline until end of follow-up, up to 899 days.</time_frame>
    <description>Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52</measure>
    <time_frame>At baseline and Week 52.</time_frame>
    <description>The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100</measure>
    <time_frame>At baseline and Week 100.</time_frame>
    <description>The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52</measure>
    <time_frame>At baseline and Week 52</time_frame>
    <description>The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100</measure>
    <time_frame>At baseline and Week 100</time_frame>
    <description>The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Change in Six-Minute Walk Test (6MWT) at Week 52</measure>
    <time_frame>At baseline and Week 52.</time_frame>
    <description>Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Annual Change in Six-Minute Walk Test (6MWT) at Week 100</measure>
    <time_frame>At baseline and Week 100.</time_frame>
    <description>Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From baseline until end of follow-up, up to 899 days.</time_frame>
    <description>Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Per Death Reason Categories</measure>
    <time_frame>From baseline until end of follow-up, up to 899 days.</time_frame>
    <description>Number of participants per death reason categories was reported.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>patients with idiopathic pulmonary fibrosis (IPF)</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nintedanib</intervention_name>
    <description>Drug</description>
    <arm_group_label>patients with idiopathic pulmonary fibrosis (IPF)</arm_group_label>
    <other_name>OVEF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pirfenidone</intervention_name>
    <description>Drug</description>
    <arm_group_label>patients with idiopathic pulmonary fibrosis (IPF)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be carried out at 10 medical centers, the expert centers where idiopathic&#xD;
        pulmonary fibrosis (IPF) patients are mainly managed in Taiwan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients can be included if ALL the following criteria are met:&#xD;
&#xD;
             1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF&#xD;
             guideline (Ref 1, Raghu G, et al. 2011).&#xD;
&#xD;
          -  Exclusion of other known causes of ILD (e.g. domestic and occupational environmental&#xD;
             exposures, connective tissue disease, and drug toxicity).&#xD;
&#xD;
          -  Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available.&#xD;
             2.Patient ≥ 20 years of age 3.Written informed consent prior to participation&#xD;
             4.Patients with further follow-up possible with participating physician during planned&#xD;
             study period 5.Ability to read and write in the local language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients should not be included if ANY of the following criteria is met:&#xD;
&#xD;
               1. Lung transplantation expected within next 6 months.&#xD;
&#xD;
               2. Inclusion in ongoing clinical trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chang-Hua Christian Hospital</name>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Medical University Chung-Ho Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>807</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>New Taipei</city>
        <zip>220</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>China Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>404</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taichung Veterans General Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tri-Service General Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>114</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital(Linkou)</name>
      <address>
        <city>Tao-Yuan</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <link>
    <url>http://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>February 15, 2021</results_first_submitted>
  <results_first_submitted_qc>February 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 8, 2021</results_first_posted>
  <last_update_submitted>March 19, 2021</last_update_submitted>
  <last_update_submitted_qc>March 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pirfenidone</mesh_term>
    <mesh_term>Nintedanib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03242759/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03242759/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This was a non-interventional multi-center study based on newly collected data on idiopathic pulmonary fibrosis (IPF) patients in clinical practice in Taiwan with a planned 2-year followed-up period to characterize the IPF population in Taiwan with regard to their clinical course under clinical practice conditions in Taiwan.</recruitment_details>
      <pre_assignment_details>All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.&#xD;
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
          <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
        </group>
        <group group_id="P2">
          <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
          <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Administrative problems</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Change visit schedule</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
      <group_list>
        <group group_id="B1">
          <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
          <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
        </group>
        <group group_id="B2">
          <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
          <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="88"/>
            <count group_id="B2" value="13"/>
            <count group_id="B3" value="101"/>
          </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="74.7" spread="8.97"/>
                    <measurement group_id="B2" value="74.1" spread="10.64"/>
                    <measurement group_id="B3" value="74.6" spread="9.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Oriental</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent predicted Forced Vital Capacity (FVC) of lung function</title>
          <description>Baseline measures of percentages of predicted Forced Vital Capacity of lung function (FVC) were shown.</description>
          <units>Percentage of predicted FVC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.7" spread="14.06"/>
                    <measurement group_id="B2" value="97.8" spread="10.97"/>
                    <measurement group_id="B3" value="73.3" spread="16.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) of lung function</title>
          <description>Baseline measures of the percentages of predicted diffusing capacity of the Lungs for Carbon monoxide (DLco) were shown.</description>
          <units>Percentage of perdicted DLco</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.7" spread="19.74"/>
                    <measurement group_id="B2" value="57.5" spread="17.96"/>
                    <measurement group_id="B3" value="45.2" spread="20.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent predicted oxygen saturation (SpO2)</title>
          <description>Baseline measures of percentages of predicted oxygen saturation (SpO2) were shown.</description>
          <units>Percentage of predicted SpO2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95.5" spread="2.31"/>
                    <measurement group_id="B2" value="97.5" spread="1.69"/>
                    <measurement group_id="B3" value="95.8" spread="2.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent predicted Total Lung Capacity (TLC)</title>
          <description>Baseline measures of the percentages of predicted Total Lung Capacity (TLC) were shown.</description>
          <units>Percentage of perdicted TLC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.3" spread="13.25"/>
                    <measurement group_id="B2" value="100.2" spread="13.04"/>
                    <measurement group_id="B3" value="77.2" spread="15.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Percent predicted Inspiratory Capacity (IC)</title>
          <description>Baseline measures of the percentages of predicted Inspiratory Capacity (IC) were shown.</description>
          <units>Percentage of perdicted IC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.8" spread="15.62"/>
                    <measurement group_id="B2" value="87.5" spread="21.49"/>
                    <measurement group_id="B3" value="65.6" spread="17.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52</title>
        <description>Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.</description>
        <time_frame>At baseline and Week 52.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52</title>
          <description>Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted FVC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="10.78"/>
                    <measurement group_id="O2" value="4.1" spread="7.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.505</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.181</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100</title>
        <description>Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.</description>
        <time_frame>At baseline and Week 100.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100</title>
          <description>Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted FVC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="7.74"/>
                    <measurement group_id="O2" value="-2.5" spread="4.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.571</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.232</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52</title>
        <description>Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported</description>
        <time_frame>At baseline and Week 52.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52</title>
          <description>Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted DLco</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.3" spread="10.47"/>
                    <measurement group_id="O2" value="-2.8" spread="8.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.375</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100</title>
        <description>Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.</description>
        <time_frame>At baseline and Week 100.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100</title>
          <description>Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted DLco</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="6.83"/>
                    <measurement group_id="O2" value="-2.6" spread="6.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.027</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.938</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52</title>
        <description>Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.</description>
        <time_frame>At baseline and Week 52.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52</title>
          <description>Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted SpO2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="2.22"/>
                    <measurement group_id="O2" value="-0.8" spread="0.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.048</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100</title>
        <description>Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.</description>
        <time_frame>At baseline and Week 100.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100</title>
          <description>Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted SpO2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.96"/>
                    <measurement group_id="O2" value="-0.6" spread="0.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.018</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.125</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52</title>
        <description>Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.</description>
        <time_frame>At baseline and Week 52.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52</title>
          <description>Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted TLC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.4" spread="9.97"/>
                    <measurement group_id="O2" value="-1.4" spread="12.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.073</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.755</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100</title>
        <description>Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.</description>
        <time_frame>At baseline and Week 100.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100</title>
          <description>Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted TLC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.3" spread="3.76"/>
                    <measurement group_id="O2" value="-3.4" spread="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.281</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52</title>
        <description>Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.</description>
        <time_frame>At baseline and Week 52.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52</title>
          <description>Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted IC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.8" spread="10.18"/>
                    <measurement group_id="O2" value="-6.1" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.008</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100</title>
        <description>Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.</description>
        <time_frame>At baseline and Week 100.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100</title>
          <description>Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Percentage of predicted IC</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.5" spread="5.00"/>
                    <measurement group_id="O2" value="-6.0" spread="2.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.031</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis</title>
        <description>Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.</description>
        <time_frame>From baseline until end of follow-up, up to 899 days.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis</title>
          <description>Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497.0" lower_limit="6.0" upper_limit="751.0"/>
                    <measurement group_id="O2" value="521.5" lower_limit="111.0" upper_limit="721.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52</title>
        <description>The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.</description>
        <time_frame>At baseline and Week 52.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52</title>
          <description>The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" spread="16.52"/>
                    <measurement group_id="O2" value="0.2" spread="8.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.001</p_value>
            <method>Paired t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.939</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100</title>
        <description>The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.</description>
        <time_frame>At baseline and Week 100.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100</title>
          <description>The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="13.36"/>
                    <measurement group_id="O2" value="1.6" spread="6.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.169</p_value>
            <method>Paired t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.545</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52</title>
        <description>The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.</description>
        <time_frame>At baseline and Week 52</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52</title>
          <description>The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="7.80"/>
                    <measurement group_id="O2" value="0.2" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.333</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.786</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100</title>
        <description>The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.</description>
        <time_frame>At baseline and Week 100</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100</title>
          <description>The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="4.37"/>
                    <measurement group_id="O2" value="0.7" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.245</p_value>
            <method>Paired t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.454</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Change in Six-Minute Walk Test (6MWT) at Week 52</title>
        <description>Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.</description>
        <time_frame>At baseline and Week 52.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change in Six-Minute Walk Test (6MWT) at Week 52</title>
          <description>Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.6" spread="60.42"/>
                    <measurement group_id="O2" value="7.1" spread="31.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.543</p_value>
            <method>Paired t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.733</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Annual Change in Six-Minute Walk Test (6MWT) at Week 100</title>
        <description>Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.</description>
        <time_frame>At baseline and Week 100.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Change in Six-Minute Walk Test (6MWT) at Week 100</title>
          <description>Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Meter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.7" spread="36.60"/>
                    <measurement group_id="O2" value="-2.3" spread="20.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.046</p_value>
            <method>Paired t-test</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intra-group difference comparing to baseline was analyzed.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.898</p_value>
            <method>Paired t-test</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.</description>
        <time_frame>From baseline until end of follow-up, up to 899 days.</time_frame>
        <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.</description>
          <population>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="686.0" lower_limit="14.0" upper_limit="899.0"/>
                    <measurement group_id="O2" value="641.0" lower_limit="111.0" upper_limit="721.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Per Death Reason Categories</title>
        <description>Number of participants per death reason categories was reported.</description>
        <time_frame>From baseline until end of follow-up, up to 899 days.</time_frame>
        <population>All eligible patients who died during the study. All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
            <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Per Death Reason Categories</title>
          <description>Number of participants per death reason categories was reported.</description>
          <population>All eligible patients who died during the study. All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related to idiopathic pulmonary fibrosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related to comorbidity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline until end of follow-up, up to 899 days.</time_frame>
      <desc>All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.</desc>
      <group_list>
        <group group_id="E1">
          <title>Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug</title>
          <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.</description>
        </group>
        <group group_id="E2">
          <title>Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug</title>
          <description>Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia of chronic disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Intraventricular haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </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="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Idiopathic pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase abnormal</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="13"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="13"/>
              </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>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.&#xD;
Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.&#xD;
BI may request a delay of the publication in order to protect BI's intellectual property rights.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03242759
org study id: 1199-0303
nct id: NCT03242759
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a non-interventional, multi-center study to collect data from patients with
      idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried
      out at 10 medical centers, the expert centers where IPF patients are mainly managed in
      Taiwan.
observational model: Cohort
time perspective: Prospective
measure: Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
time frame: At baseline and Week 52.
description: Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
measure: Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100
time frame: At baseline and Week 100.
description: Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.
measure: Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52
time frame: At baseline and Week 52.
description: Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported
measure: Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100
time frame: At baseline and Week 100.
description: Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.
measure: Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52
time frame: At baseline and Week 52.
description: Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.
measure: Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100
time frame: At baseline and Week 100.
description: Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.
measure: Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52
time frame: At baseline and Week 52.
description: Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.
measure: Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100
time frame: At baseline and Week 100.
description: Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.
measure: Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52
time frame: At baseline and Week 52.
description: Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.
measure: Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100
time frame: At baseline and Week 100.
description: Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.
measure: Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis
time frame: From baseline until end of follow-up, up to 899 days.
description: Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.
measure: Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52
time frame: At baseline and Week 52.
description: The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.
measure: Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100
time frame: At baseline and Week 100.
description: The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.
measure: Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52
time frame: At baseline and Week 52
description: The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.
measure: Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100
time frame: At baseline and Week 100
description: The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.
measure: Annual Change in Six-Minute Walk Test (6MWT) at Week 52
time frame: At baseline and Week 52.
description: Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.
measure: Annual Change in Six-Minute Walk Test (6MWT) at Week 100
time frame: At baseline and Week 100.
description: Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.
measure: Overall Survival
time frame: From baseline until end of follow-up, up to 899 days.
description: Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.
measure: Number of Participants Per Death Reason Categories
time frame: From baseline until end of follow-up, up to 899 days.
description: Number of participants per death reason categories was reported.
arm group label: patients with idiopathic pulmonary fibrosis (IPF)
intervention type: Drug
intervention name: nintedanib
description: Drug
arm group label: patients with idiopathic pulmonary fibrosis (IPF)
other name: OVEF
intervention type: Drug
intervention name: pirfenidone
description: Drug
arm group label: patients with idiopathic pulmonary fibrosis (IPF)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
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country: Taiwan
url: http://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Pirfenidone
mesh term: Nintedanib
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 