<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/NCT03281200</url>
  </required_header>
  <id_info>
    <org_study_id>1199-0295</org_study_id>
    <nct_id>NCT03281200</nct_id>
  </id_info>
  <brief_title>Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain</brief_title>
  <official_title>A Multicentre, Retrospective Chart Review Study to Describe the Clinical Profile of Idiopathic Pulmonary Fibrosis (IPF) Patients Treated With Nintedanib (OFEV®) in Real-world Practice in Spain.</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>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study has been designed to characterize IPF patients treated with nintedanib&#xD;
      (OFEV®), at time of treatment initiation, with respect to their clinical profile based on&#xD;
      real-world data from January 2016 in Spanish Pulmonology Services.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2017</start_date>
  <completion_date type="Actual">June 7, 2018</completion_date>
  <primary_completion_date type="Actual">June 7, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clinical Baseline Characteristics - Duration of the Disease</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clinical Baseline Characteristics - Percentage of Patients With Emphysema</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Demographic Baseline Characteristics - 6-minute Walk Test</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)</measure>
    <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
    <description>The distribution of patients across different lung function categories based on the reimbursement threshold (FVC &gt;80%, 50-80%, and &lt;50%).</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">172</enrollment>
  <condition>Idiopathic Pulmonary Fibrosis</condition>
  <arm_group>
    <arm_group_label>Anatomical main group:</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Therapeutic subgroup</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Pharmacological subgroup</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemical subgroup</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemical substance</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L - Antineoplastic and immunomodulating agents</intervention_name>
    <description>L - Antineoplastic and immunomodulating agents</description>
    <arm_group_label>Anatomical main group:</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L01 - Antineoplastic agents</intervention_name>
    <description>L01 - Antineoplastic agents</description>
    <arm_group_label>Therapeutic subgroup</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L01X - Other antineoplastic agents</intervention_name>
    <description>L01X - Other antineoplastic agents</description>
    <arm_group_label>Pharmacological subgroup</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L01XE - Protein kinase inhibitors</intervention_name>
    <description>L01XE - Protein kinase inhibitors</description>
    <arm_group_label>Chemical subgroup</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>L01XE31 - Nintedanib</intervention_name>
    <description>L01XE31 - Nintedanib</description>
    <arm_group_label>Chemical substance</arm_group_label>
    <other_name>OVEF</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Approximately 175 IPF patients from 35 Pulmonology Services in Spain are planned to be&#xD;
        included in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient is at least 18 years old&#xD;
&#xD;
          -  The patient has IPF diagnosis according to most recent ATS/ERS/JRS/ALAT IPF guideline&#xD;
             for diagnosis and management [5]&#xD;
&#xD;
          -  The patient newly initiated treatment with nintedanib (OFEV®) since 01 January 2016 up&#xD;
             to end of data collection date, according to the approved local Summary of Product&#xD;
             Characteristics (SmPC)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients treated with nintedanib within a clinical trial or named-patient program or with&#xD;
        any prior treatment of nintedanib.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dynamic solutions</name>
      <address>
        <city>Barcelona</city>
        <zip>08029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>June 6, 2019</results_first_submitted>
  <results_first_submitted_qc>June 6, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 1, 2019</results_first_posted>
  <last_update_submitted>June 6, 2019</last_update_submitted>
  <last_update_submitted_qc>June 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2019</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>
    <mesh_term>Idiopathic Pulmonary Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nintedanib</mesh_term>
    <mesh_term>Antineoplastic Agents</mesh_term>
    <mesh_term>Protein Kinase Inhibitors</mesh_term>
    <mesh_term>Immunomodulating Agents</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03281200/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Non-interventional study based on medical charts was conducted in approximately 35 pulmonology services in Spanish hospitals. Idiopathic pulmonary fibrosis (IPF) patients were characterized at the time of nintedanib initiation. Analysis of this report was performed using the data collected in the database from 21October2017 up to 31January2018.</recruitment_details>
      <pre_assignment_details>All participants were screened for eligibility to participate in the study. Participants attended specialist sites which would then ensure that all participants met all inclusion/exclusion criteria. Participants were not to be analyzed if any one of the specific entry criteria were not met.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Total Patients With IPF</title>
          <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled patients who met the selection criteria.</population>
      <group_list>
        <group group_id="B1">
          <title>Total Patients With IPF</title>
          <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="172"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age at the time of baseline visit</description>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71.0" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Particpants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Male</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>Ethnicity data was not collected for this trial.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Caucasian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asiatic</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arab</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="172"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))</title>
        <description>The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))</title>
          <description>The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentage of Patients (%)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild IPF: FVC ≥ 70%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate IPF: FVC between 50% and 69%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe IPF: FVC &lt; 50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))</title>
        <description>The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.Include only those patients DLCO value who has been answered in the case report form (CRF).</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))</title>
          <description>The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.</description>
          <population>All enrolled patients who met the selection criteria.Include only those patients DLCO value who has been answered in the case report form (CRF).</population>
          <units>Percentage of Patients (%)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="153"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild IPF: DLCO ≥ 50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate IPF: DLCO between 35% and 49%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe IPF: DLCO &lt; 35%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation</title>
        <description>The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation</title>
          <description>The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.1" spread="8.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clinical Baseline Characteristics - Duration of the Disease</title>
        <description>Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Clinical Baseline Characteristics - Duration of the Disease</title>
          <description>Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clinical Baseline Characteristics - Percentage of Patients With Emphysema</title>
        <description>The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Clinical Baseline Characteristics - Percentage of Patients With Emphysema</title>
          <description>The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern</title>
        <description>The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern</title>
          <description>The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern</title>
        <description>The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern</title>
          <description>The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®</title>
        <description>The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®</title>
          <description>The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>150 mg/12 h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>100 mg/12 h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy</title>
        <description>The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy</title>
          <description>The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Kilogram (Kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy</title>
        <description>The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy</title>
          <description>The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Centimeters (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164.5" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy</title>
        <description>The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy</title>
          <description>The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Kilogram/ meter^2 (kg/m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Demographic Baseline Characteristics - 6-minute Walk Test</title>
        <description>The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Demographic Baseline Characteristics - 6-minute Walk Test</title>
          <description>The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Meter (m)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="421.7" spread="118.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit</title>
        <description>The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit</title>
          <description>The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Never smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Former smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Active smoker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea</title>
        <description>The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea</title>
          <description>The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Partients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations</title>
        <description>The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations</title>
          <description>The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments</title>
        <description>The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments</title>
          <description>The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.</title>
        <description>The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.</title>
          <description>The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyslipidaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastroesophageal reflux</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emphysema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiovascular disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Obstructive sleep apnoea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulmonary hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lung cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pulmonary infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.</title>
        <description>The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.</title>
          <description>The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)</title>
        <description>The distribution of patients across different lung function categories based on the reimbursement threshold (FVC &gt;80%, 50-80%, and &lt;50%).</description>
        <time_frame>From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.</time_frame>
        <population>All enrolled patients who met the selection criteria.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Patients With IPF</title>
            <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)</title>
          <description>The distribution of patients across different lung function categories based on the reimbursement threshold (FVC &gt;80%, 50-80%, and &lt;50%).</description>
          <population>All enrolled patients who met the selection criteria.</population>
          <units>Percentages of Patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="172"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild IPF: FVC &gt; 80%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.1" lower_limit="26.3" upper_limit="40.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate IPF: FVC between 50% and 80%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.2" lower_limit="54.5" upper_limit="69.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe IPF: FVC &lt; 50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="2.2" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of drug administration (01Jan16) until final data set (07Jun18). i.e. Up to 889 days</time_frame>
      <desc>Patients who enrolled in the study and met the selection criteria used for reporting adverse events</desc>
      <group_list>
        <group group_id="E1">
          <title>Total Patients With IPF</title>
          <description>The IPF patients who initiated treatment with nintedanib (OFEV®) from 01January2016 up to 07June2018.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatotoxicity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Idiopathic pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
              <event>
                <sub_title>Pulmonary arterial hypertension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="172"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="172"/>
              </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. 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. 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/NCT03281200
org study id: 1199-0295
nct id: NCT03281200
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The present study has been designed to characterize IPF patients treated with nintedanib
      (OFEV®), at time of treatment initiation, with respect to their clinical profile based on
      real-world data from January 2016 in Spanish Pulmonology Services.
observational model: Other
time perspective: Retrospective
measure: Percentage of Patients Across Different Lung Function Categories (% FVC (Forced Vital Capacity))
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The distribution of patients across different lung function categories (% FVC serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
measure: Percentage of Patients Across Different Lung Function Categories (% DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide))
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The distribution of patients across different lung function categories (% DLCO serving as surrogate markers for IPF severity) of IPF patients treated with nintedanib (OFEV®) in routine clinical practice, at the time of treatment initiation.
measure: The Demographic Baseline Characteristics - Age at the Time of Treatment Initiation
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The age of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
measure: The Clinical Baseline Characteristics - Duration of the Disease
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: Duration of the disease of IPF patients, calculated as the time elapsed from the date of diagnosis until the start date of treatment with OFEV® (years).
measure: The Clinical Baseline Characteristics - Percentage of Patients With Emphysema
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The percentage of patients with emphysema at the start of treatment with nintedanib (OFEV®) is presented.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Usual Interstitial Pneumonia (UIP) Histopathological Pattern
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The usual interstitial pneumonia (UIP) histopathological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
measure: The Clinical Baseline Characteristics - Percentage of Patients With UIP Radiological Pattern
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The UIP radiological pattern of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
measure: The Clinical Baseline Characteristics - Percentage of Patients With the Initial Dose of OFEV®
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The percentage of patients initiated OFEV® dose of 150 milligram (mg)/ 12 hours (h) and 100 mg/12 h is presented.
measure: The Demographic Baseline Characteristics - Weight at the Start of Nintedanib Therapy
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The weight of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
measure: The Demographic Baseline Characteristics - Height at the Start of Nintedanib Therapy
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The height of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
measure: The Demographic Baseline Characteristics - Body Mass Index (BMI) at the Start of Nintedanib Therapy
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The body mass index (BMI) of IPF patients at the start of treatment with nintedanib (OFEV®) is presented.
measure: The Demographic Baseline Characteristics - 6-minute Walk Test
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The 6-minute walk test of IPF patients at the time of treatment initiation with nintedanib (OFEV®) is presented.
measure: The Demographic Baseline Characteristics - Percentage of Patients With Smoking Habit
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The percentage of patients with smoking habit at the start of treatment with nintedanib (OFEV®) is presented.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Dyspnoea
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The percentage of patients with dyspnoea at the start of treatment with nintedanib (OFEV®) is presented.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Exacerbations
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The percentage of patients with exacerbations of IPF in the year prior to initiating treatment is presented.
measure: The Clinical Baseline Characteristics - Percentage of Patients With Concomitant Treatments
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The percentage of patients taking any concomitant medication at the start of nintedanib therapy is presented.
measure: Percentage of Patients With Prevalence of Comorbidity (Concomitant Diseases) at the Time of Treatment Initiation.
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The percentage of patients with comorbidity (concomitant diseases) at the start of treatment with nintedanib (OFEV®) is presented.
measure: Percentage of Patients With Other Concomitant Diseases at the Time of Treatment Initiation.
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The percentage of patients with other concomitant diseases at the start of treatment with nintedanib (OFEV®) is presented.
measure: Percentage of Patients Distributed Across Different Lung Function Categories Based on the Reimbursement Threshold (%FVC)
time frame: From start of drug administration (01Jan16) until data collected in the database cut off date (31Jan18), i.e. Up to 765 days.
description: The distribution of patients across different lung function categories based on the reimbursement threshold (FVC >80%, 50-80%, and <50%).
arm group label: Anatomical main group:
arm group label: Therapeutic subgroup
arm group label: Pharmacological subgroup
arm group label: Chemical subgroup
arm group label: Chemical substance
intervention type: Drug
intervention name: L - Antineoplastic and immunomodulating agents
description: L - Antineoplastic and immunomodulating agents
arm group label: Anatomical main group:
intervention type: Drug
intervention name: L01 - Antineoplastic agents
description: L01 - Antineoplastic agents
arm group label: Therapeutic subgroup
intervention type: Drug
intervention name: L01X - Other antineoplastic agents
description: L01X - Other antineoplastic agents
arm group label: Pharmacological subgroup
intervention type: Drug
intervention name: L01XE - Protein kinase inhibitors
description: L01XE - Protein kinase inhibitors
arm group label: Chemical subgroup
intervention type: Drug
intervention name: L01XE31 - Nintedanib
description: L01XE31 - Nintedanib
arm group label: Chemical substance
other name: OVEF
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Spain
url: http://trials.boehringer-ingelheim.com/
description: Related Info
responsible party type: Sponsor
mesh term: Pulmonary Fibrosis
mesh term: Idiopathic Pulmonary Fibrosis
mesh term: Fibrosis
mesh term: Nintedanib
mesh term: Antineoplastic Agents
mesh term: Protein Kinase Inhibitors
mesh term: Immunomodulating Agents
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 