<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/NCT02999178</url>
  </required_header>
  <id_info>
    <org_study_id>1199.247</org_study_id>
    <secondary_id>2015-003360-37</secondary_id>
    <nct_id>NCT02999178</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)</brief_title>
  <acronym>INBUILD®</acronym>
  <official_title>A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nintedanib Over 52 Weeks in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the current study is to investigate the efficacy and safety of nintedanib over 52&#xD;
      weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as&#xD;
      patients who present with features of diffuse fibrosing lung disease of &gt;10% extent on&#xD;
      high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms&#xD;
      or chest imaging have worsened despite treatment with unapproved medications used in clinical&#xD;
      practice to treat ILD. There is currently no efficacious treatment available for PF-ILD.&#xD;
      Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated&#xD;
      that Nintedanib will be a new treatment option for patients with PF-ILD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">August 12, 2019</completion_date>
  <primary_completion_date type="Actual">April 23, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Annual Rate of Decline in Forced Vital Capacity - Overall Population</measure>
    <time_frame>Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
    <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Overall population consists of all randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only or HRCT fibrotic pattern= Other fibrotic patterns. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in the overall population is based on a random coefficient regression with fixed effects for treatment, HRCT fibrotic pattern, and baseline FVC [mL], and including treatment-by-time and baseline-by-time interactions. Within-participant errors are modelled by an unstructured variance-covariance matrix.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
    <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only is based on a random coefficient regression with fixed effects for treatment, baseline FVC [mL], and including treatment-by-time and baseline-by-time interactions. Within-participant errors are modelled by an unstructured variance-covariance matrix.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 52 - Overall Population</measure>
    <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
    <description>King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were &gt;50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population was based on a Mixed Model Repeated Measures (MMRM), with fixed effects for baseline K-BILD Total score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interactions and random effect for participant. Visit was the repeated measure. Within-participant errors were modelled by unstructured variance-covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
    <description>King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were &gt;50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only was based on a Mixed Model Repeated Measures (MMRM), with fixed effects for baseline K-BILD Total score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interactions and random effect for participant. Visit was the repeated measure. Within-participant errors were modelled by unstructured variance-covariance matrix.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Overall Population</measure>
    <time_frame>From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days</time_frame>
    <description>Time to first acute ILD exacerbation or death over 52 weeks was defined as time to first acute ILD exacerbation or death due to any cause within the first 52 weeks and was computed as earliest of date of first documented acute ILD exacerbation or death - date of first drug intake + 1. Participants alive who did not experience any ILD exacerbation event or with unknown status within the first 52 weeks were censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days</time_frame>
    <description>Time to first acute ILD exacerbation or death over 52 weeks was defined as time to first acute ILD exacerbation or death due to any cause within the first 52 weeks and was computed as earliest of date of first documented acute ILD exacerbation or death - date of first drug intake + 1. Participants alive who did not experience any ILD exacerbation event or with unknown status within the first 52 weeks were censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death Over 52 Weeks - Overall Population</measure>
    <time_frame>From first drug intake until date of death or last contact date, up to 372 days</time_frame>
    <description>Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause) within the first 52 weeks. Participants with no event (death from any cause) or unknown status within the first 52 weeks were censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>From first drug intake until date of death or last contact date, up to 372 days</time_frame>
    <description>Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause) within the first 52 weeks. Participants with no event (death from any cause) or unknown status within the first 52 weeks were censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death Due to Respiratory Cause Over 52 Weeks - Overall Population</measure>
    <time_frame>From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days</time_frame>
    <description>Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes (determined by an independent Adjudication Committee) for participants with known date of death (from respiratory causes) within the first 52 weeks. Participants with no event (death from respiratory causes) or unknown status within the first 52 weeks were censored. As less than 4.95% of the total of participants in the analysis population experienced an event, only descriptive statistics were performed, as pre-specified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death Due to Respiratory Cause Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days</time_frame>
    <description>Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes (determined by an independent Adjudication Committee) for participants with known date of death (from respiratory causes) within the first 52 weeks. Participants with no event (death from respiratory causes) or unknown status within the first 52 weeks were censored. As less than 4.95% of the total of participants in the analysis population experienced an event, only descriptive statistics were performed, as pre-specified.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression or Death Over 52 Weeks - Overall Population</measure>
    <time_frame>From first drug intake until date of progression or date of death or last contact date, up to 372 days</time_frame>
    <description>Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Participants with no event (progression or death from any cause) or unknown status were censored. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occured for the first time. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>From first drug intake until date of progression or date of death or last contact date, up to 372 days</time_frame>
    <description>Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Participants with no event (progression or death from any cause) or unknown status were censored. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occured for the first time. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Overall Population</measure>
    <time_frame>Baseline and up to 52 weeks after first drug intake</time_frame>
    <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 10% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 10% and those participants with missing data (worst case analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>Baseline and up to 52 weeks after first drug intake</time_frame>
    <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 10% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 10% and those participants with missing data (worst case analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Overall Population</measure>
    <time_frame>Baseline and up to 52 weeks after first drug intake</time_frame>
    <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 5% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 5% and those participants with missing data (worst case analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>Baseline and up to 52 weeks after first drug intake</time_frame>
    <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 5% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 5% and those participants with missing data (worst case analysis).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 - Overall Population</measure>
    <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
    <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in L-PF Symptoms Dyspnea Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
    <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in L-PF Symptoms Cough Domain Score at Week 52 - Overall Population</measure>
    <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
    <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</measure>
    <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
    <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">663</enrollment>
  <condition>Lung Diseases, Interstitial</condition>
  <arm_group>
    <arm_group_label>Nintedanib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nintedanib</intervention_name>
    <arm_group_label>Nintedanib</arm_group_label>
    <other_name>OVEF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Written Informed Consent consistent with International Conference on Harmonisation&#xD;
             Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local laws&#xD;
             signed prior to entry into the study (and prior to any study procedure including&#xD;
             shipment of High Resolution Computer Tomography (HRCT) to reviewer).&#xD;
&#xD;
          -  Male or female patients aged &gt;= 18 years at Visit 1.&#xD;
&#xD;
          -  Patients with physician diagnosed Interstitial Lung Disease (ILD) who fulfil at least&#xD;
             one of the following criteria for Progressive Fibrosing Interstitial Lung Disease&#xD;
             (PF-ILD) within 24 months of screening visit (Visit 1) despite treatment with&#xD;
             unapproved medications used in clinical practice to treat ILD, as assessed by the&#xD;
             investigator (refer to Exclusion Criteria):&#xD;
&#xD;
               -  Clinically significant decline in Forced Vital Capacity (FVC) % pred based on a&#xD;
                  relative decline of &gt;=10%&#xD;
&#xD;
               -  Marginal decline in FVC % pred based on a relative decline of .&gt;=5-&lt;10% combined&#xD;
                  with worsening of respiratory symptoms&#xD;
&#xD;
               -  Marginal decline in FVC % pred based on a relative decline of &gt;=5-&lt;10% combined&#xD;
                  with increasing extent of fibrotic changes on chest imaging&#xD;
&#xD;
               -  Worsening of respiratory symptoms as well as increasing extent of fibrotic&#xD;
                  changes on chest imaging [Note: Changes attributable to comorbidities e.g.&#xD;
                  infection, heart failure must be excluded. Unapproved medications used in the&#xD;
                  clinical practice to treat ILD include but are not limited to corticosteroid,&#xD;
                  azathioprine, mycophenolate mofetil (MMF), n-acetylcysteine (NAC), rituximab,&#xD;
                  cyclophosphamide, cyclosporine, tacrolimus].&#xD;
&#xD;
          -  Fibrosing lung disease on HRCT, defined as reticular abnormality with traction&#xD;
             bronchiectasis with or without honeycombing, with disease extent of &gt;10%, performed&#xD;
             within 12 months of Visit 1 as confirmed by central readers.&#xD;
&#xD;
          -  For patients with underlying Connective Tissue Disease (CTD): stable CTD as defined by&#xD;
             no initiation of new therapy or withdrawal of therapy for CTD within 6 weeks prior to&#xD;
             Visit 1.&#xD;
&#xD;
          -  Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) [visit 1] ≥&#xD;
             30% and &lt;80% predicted of normal at Visit 2&#xD;
&#xD;
          -  FVC &gt;= 45% predicted at Visit 2&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) &gt; 1.5 x Upper Limit&#xD;
             of Normal (ULN) at Visit 1&#xD;
&#xD;
          -  Bilirubin &gt; 1.5 x ULN at Visit 1&#xD;
&#xD;
          -  Creatinine clearance &lt;30 mL/min calculated by Cockcroft-Gault formula at Visit 1&#xD;
             [Note: Laboratory parameters from Visit 1 have to satisfy the laboratory threshold&#xD;
             values as shown above. Visit 2 laboratory results will be available only after&#xD;
             randomization. In case at Visit 2 the results do no longer satisfy the entry criteria,&#xD;
             the Investigator has to decide whether it is justified that the patient remains on&#xD;
             study drug. The justification for decision needs to be documented. Laboratory&#xD;
             parameters that are found to be abnormal at Visit 1 are allowed to be re-tested (once)&#xD;
             if it is thought to be a measurement error (i.e. there was no abnormal result of this&#xD;
             test in the recent history of the patient and there is no related clinical sign) or&#xD;
             the result of a temporary and reversible medical condition, once that condition is&#xD;
             resolved].&#xD;
&#xD;
          -  Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic&#xD;
             impairment).&#xD;
&#xD;
          -  Previous treatment with nintedanib or pirfenidone.&#xD;
&#xD;
          -  Other investigational therapy received within 1 month or 6 half-lives (whichever was&#xD;
             greater) prior to screening visit (Visit 1).&#xD;
&#xD;
          -  Use of any of the following medications for the treatment of Interstitial Lung Disease&#xD;
             (ILD): azathioprine (AZA), cyclosporine, MMF, tacrolimus, oral corticosteroids (OCS)&#xD;
             &gt;20mg/day and the combination of OCS+AZA+NAC within 4 weeks of Visit 2,&#xD;
             cyclophosphamide within 8 weeks of Visit 2, rituximab within 6 months of Visit 2.&#xD;
&#xD;
        Note: Patients whose Rheumatoid Arthritis (RA)/Connective Tissue Disease (CTD) is managed&#xD;
        by these medications should not be considered for participation in the current study unless&#xD;
        change in RA/CTD medication is medically indicated (see Inclusion Criteria)&#xD;
&#xD;
          -  Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on American Thoracic Society&#xD;
             (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin&#xD;
             American Thoracic Association (ALAT) 2011 Guidelines.&#xD;
&#xD;
          -  Significant Pulmonary Arterial Hypertension (PAH) defined by any of the following:&#xD;
&#xD;
               -  Previous clinical or echocardiographic evidence of significant right heart&#xD;
                  failure&#xD;
&#xD;
               -  History of right heart catheterization showing a cardiac index &lt;= 2 l/min/m²&#xD;
&#xD;
               -  PAH requiring parenteral therapy with epoprostenol/treprostinil&#xD;
&#xD;
               -  Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC &lt; 0.7 at Visit&#xD;
                  1).&#xD;
&#xD;
               -  In the opinion of the Investigator, other clinically significant pulmonary&#xD;
                  abnormalities.&#xD;
&#xD;
          -  Major extrapulmonary physiological restriction (e.g. chest wall abnormality, large&#xD;
             pleural effusion)&#xD;
&#xD;
          -  Cardiovascular diseases, any of the following:&#xD;
&#xD;
               -  Severe hypertension, uncontrolled under treatment (≥160/100 mmHg), within 6 month&#xD;
                  of Visit 1&#xD;
&#xD;
               -  Myocardial infarction within 6 months of Visit 1&#xD;
&#xD;
               -  Unstable cardiac angina within 6 months of Visit 1&#xD;
&#xD;
          -  Bleeding risk, any of the following:&#xD;
&#xD;
               -  Known genetic predisposition to bleeding.&#xD;
&#xD;
               -  Patients who require&#xD;
&#xD;
                    -  Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K&#xD;
                       antagonists, direct thrombin inhibitors, heparin, hirudin)&#xD;
&#xD;
                    -  High dose antiplatelet therapy. [Note: Prophylactic low dose heparin or&#xD;
                       heparin flush as needed for maintenance of an indwelling intravenous device&#xD;
                       (e.g. enoxaparin 4000 I.U. s.c. per day), as well as prophylactic use of&#xD;
                       antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/day, or&#xD;
                       clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy)&#xD;
                       are not prohibited].&#xD;
&#xD;
               -  History of haemorrhagic central nervous system (CNS) event within 12 months of&#xD;
                  Visit 1.&#xD;
&#xD;
               -  Any of the following within 3 months of Visit 1:&#xD;
&#xD;
                    -  Haemoptysis or haematuria&#xD;
&#xD;
                    -  Active gastro-intestinal (GI) bleeding or GI - ulcers&#xD;
&#xD;
                    -  Major injury or surgery (Investigators judgment).&#xD;
&#xD;
               -  Coagulation parameters: International normalized ratio (INR) &gt;2, prolongation of&#xD;
                  prothrombin time (PT) and activated partial thromboplastin time (aPTT) by &gt;1.5 x&#xD;
                  ULN at Visit 1.&#xD;
&#xD;
          -  History of thrombotic event (including stroke and transient ischemic attack) within 12&#xD;
             months of Visit 1.&#xD;
&#xD;
          -  Known hypersensitivity to the trial medication or its components (i.e. soya lecithin)&#xD;
&#xD;
          -  Patients with peanut allergy.&#xD;
&#xD;
          -  Other disease that may interfere with testing procedures or in the judgment of the&#xD;
             Investigator may interfere with trial participation or may put the patient at risk&#xD;
             when participating in this trial.&#xD;
&#xD;
          -  Life expectancy for disease other than ILD &lt; 2.5 years (Investigator assessment).&#xD;
&#xD;
          -  Planned major surgical procedures.&#xD;
&#xD;
          -  Women who are pregnant, nursing, or who plan to become pregnant while in the trial.&#xD;
&#xD;
          -  Women of childbearing potential* not willing or able to use highly effective methods&#xD;
             of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per&#xD;
             year when used consistently and correctly as well as one barrier method for 28 days&#xD;
             prior to and 3 months after nintedanib administration. A list of contraception methods&#xD;
             meeting these criteria is provided in the patient information.&#xD;
&#xD;
          -  In the opinion of the Investigator, active alcohol or drug abuse.&#xD;
&#xD;
          -  Patients not able to understand or follow trial procedures including completion of&#xD;
             self-administered questionnaires without help. *A woman is considered of childbearing&#xD;
             potential, i.e. fertile, following menarche and until becoming post-menopausal unless&#xD;
             permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral&#xD;
             salpingectomy and bilateral oophorectomy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Jewish Health</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary and Sleep Specialists</name>
      <address>
        <city>Danbury</city>
        <state>Connecticut</state>
        <zip>06810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary and Sleep of Tampa Bay</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida College of Medicine</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky Medical Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary and Critical Care Associates of Baltimore</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21286</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary and Critical Care Medicine</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49546</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Masonic Cancer Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic, Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Lung Research Center, LLC</name>
      <address>
        <city>Chesterfield</city>
        <state>Missouri</state>
        <zip>63017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Creighton University</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center-New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NewYork-Presbyterian/Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeastern Research Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oregon Clinic</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oregon Clinic</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S. Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Oaks</city>
        <state>Pennsylvania</state>
        <zip>19456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of South Carolina</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Pul &amp; Crit Care Conslt</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostics Research Group</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Arts and Research Center (MARC)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Health Sciences Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Medical Campus</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary Associates of Richmond, Inc.</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Dr. Lazaro Langer S.R.L</name>
      <address>
        <city>Alberdi Sur</city>
        <zip>X5003DCE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigaciones Metabólicas (CINME)</name>
      <address>
        <city>C.a.b.a</city>
        <zip>1056</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanatorio Güemes</name>
      <address>
        <city>Ciudad Autónoma de Bs As</city>
        <zip>C1180AAX</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEMER-Centro Medico De Enfermedades Respiratorias</name>
      <address>
        <city>Florida</city>
        <zip>B1602DQD</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INSARES</name>
      <address>
        <city>Mendoza</city>
        <zip>M5500CCG</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Médico de la Fundación Estudios Clínicos</name>
      <address>
        <city>Rosario</city>
        <zip>S2000DEJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Liège</name>
      <address>
        <city>Angleur</city>
        <zip>4031</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ULB Hopital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yvoir - UNIV UCL de Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Concordia Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2K 3S8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph's Healthcare Hamilton</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N 4A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHUS Fleurimont</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <zip>J1H 5N4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Reg. de Concepción &quot;Dr. G. Grant Benavente&quot;</name>
      <address>
        <city>Concepción</city>
        <zip>4070038</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional del Tórax</name>
      <address>
        <city>Providencia, Santiago De Chile</city>
        <zip>7500000</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Investigación del Maule</name>
      <address>
        <city>Talca</city>
        <zip>3465586</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Chinese Medical University</name>
      <address>
        <city>Shenyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Avicenne</name>
      <address>
        <city>Bobigny</city>
        <zip>93009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Louis Pradel</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Côte de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP d'Instruction des Armées Percy</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Calmette</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Nord</name>
      <address>
        <city>Marseille</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Arnaud de Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Pasteur</name>
      <address>
        <city>Nice</city>
        <zip>06001</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Bichat</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Maison Blanche</name>
      <address>
        <city>Reims</city>
        <zip>51092</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HOP Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn AöR</name>
      <address>
        <city>Bonn</city>
        <zip>53105</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fachkrankenhaus Coswig GmbH</name>
      <address>
        <city>Coswig</city>
        <zip>01640</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik Donaustauf</name>
      <address>
        <city>Donaustauf</city>
        <zip>93093</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH</name>
      <address>
        <city>Essen</city>
        <zip>45239</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wissenschaftliches Institut Bethanien</name>
      <address>
        <city>Solingen</city>
        <zip>42699</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Petrus-Krankenhaus</name>
      <address>
        <city>Wuppertal</city>
        <zip>42283</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Policlinico Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale &quot;G.B. Morgagni - L. Pierantoni&quot; ausl forli</name>
      <address>
        <city>FORLì</city>
        <zip>47121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Policlinico di Modena</name>
      <address>
        <city>Modena</city>
        <zip>41100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O. San Gerardo di Monza</name>
      <address>
        <city>Monza</city>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Gemelli</name>
      <address>
        <city>Roma</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Senese Policlinico Santa Maria alle Scotte</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tosei General Hospital</name>
      <address>
        <city>Aichi, Seto</city>
        <zip>489-8642</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Fukuoka, Kurume</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Hokkaido, Sapporo</city>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Himeji Medical Center</name>
      <address>
        <city>Hyogo, Himeji</city>
        <zip>670-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Hyogo, Kobe</city>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ibarakihigashi National Hospial</name>
      <address>
        <city>Ibaraki, Naka-gun</city>
        <zip>319-1113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cardiovascular and Respiratory Center</name>
      <address>
        <city>Kanagawa, Yokohama</city>
        <zip>236-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saiseikai Kumamoto Hospital</name>
      <address>
        <city>Kumamoto, Kumamoto</city>
        <zip>861-4193</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Miyagi, Sendai</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki, Nagasaki</city>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kinki-Chuo Chest Medical Center</name>
      <address>
        <city>Osaka, Sakai</city>
        <zip>591-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Medical College Hospital</name>
      <address>
        <city>Osaka, Takatsuki</city>
        <zip>569-8686</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamamatsu University Hospital</name>
      <address>
        <city>Shizuoka, Hamamatsu</city>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jichi Medical University Hospital</name>
      <address>
        <city>Tochigi, Shimotsuke</city>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima, Tokushima</city>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical and Dental University</name>
      <address>
        <city>Tokyo, Bunkyo-ku</city>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Tokyo, Bunkyo-ku</city>
        <zip>113-8603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toranomon Hospital</name>
      <address>
        <city>Tokyo, Minato-ku</city>
        <zip>105-8470</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JR Tokyo General Hospital</name>
      <address>
        <city>Tokyo, Shibuya-ku</city>
        <zip>151-8528</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Health and Medicine Ctr</name>
      <address>
        <city>Tokyo, Shinjuku-ku</city>
        <zip>162-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Bucheon St.Mary's Hospital</name>
      <address>
        <city>Bucheon</city>
        <zip>14647</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center, Gdansk</name>
      <address>
        <city>Gdansk</city>
        <zip>80-214</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ.</name>
      <address>
        <city>Katowice</city>
        <zip>40-752</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norbert Barlicki University Clinical Hospital No.1, Lodz</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nat.Instit.of Tuberculosis&amp;LungDiseases,Outpat.Clin,warszawa</name>
      <address>
        <city>Warszawa</city>
        <zip>01-138</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA</name>
      <address>
        <city>Zabrze</city>
        <zip>41-803</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Res.Inst.-Compl.Iss.Cardi.Dis.</name>
      <address>
        <city>Kemerovo</city>
        <zip>650002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonology Scientific Research Institute</name>
      <address>
        <city>Moscow</city>
        <zip>105077</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Scientific Research Insitute of Tuberculosis</name>
      <address>
        <city>Moscow</city>
        <zip>107564</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moscow 1st State Med.Univ.n.a.I.M.Sechenov</name>
      <address>
        <city>Moscow</city>
        <zip>119992</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scientific Research Institute of Pulmonology</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197101</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150003</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Puerta del Mar</name>
      <address>
        <city>Cádiz</city>
        <zip>11009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Galdakao</name>
      <address>
        <city>Galdakao</city>
        <zip>48960</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Bellvitge</name>
      <address>
        <city>L'Hospitalet de Llobregat</city>
        <zip>08907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Princesa</name>
      <address>
        <city>Madrid</city>
        <zip>28006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Canarias</name>
      <address>
        <city>San Cristóbal de La Laguna</city>
        <zip>38320</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Virgen del Rocío</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Politècnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Llandough</name>
      <address>
        <city>Cardiff</city>
        <zip>CF64 2XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Infirmary of Edinburgh</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James's University Hospital</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Stoke University Hospital</name>
      <address>
        <city>Stoke-on-Trent</city>
        <zip>ST4 6QG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>April 22, 2020</results_first_submitted>
  <results_first_submitted_qc>April 22, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 5, 2020</results_first_posted>
  <last_update_submitted>April 22, 2020</last_update_submitted>
  <last_update_submitted_qc>April 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2020</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>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nintedanib</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 8, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT02999178/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>December 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT02999178/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Randomized (1:1 ratio), placebo-controlled, double-blind, parallel-group trial comparing nintedanib to placebo over a 52-week treatment period (Part A). Participants continued on blinded, randomized treatment beyond 52 weeks (Part B). Data base lock (DBL) one was on 6-June-2019, DBL two was on 11-September-2019. Overall Study Period=Part A and B.</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. 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>150 mg Nintedanib</title>
          <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="332"/>
                <participants group_id="P2" count="331"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="218">On treatment at analysis cut-off date, 12-August-2019</participants>
                <participants group_id="P2" count="231">On treatment at analysis cut-off date, 12-August-2019</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="114"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="62"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason not defined above</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated set: This set included all randomized participants who received at least 1 dose of trial medication.</population>
      <group_list>
        <group group_id="B1">
          <title>150 mg Nintedanib</title>
          <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</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="332"/>
            <count group_id="B2" value="331"/>
            <count group_id="B3" value="663"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <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="332"/>
                    <count group_id="B2" value="331"/>
                    <count group_id="B3" value="663"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.2" spread="9.7"/>
                    <measurement group_id="B2" value="66.3" spread="9.8"/>
                    <measurement group_id="B3" value="65.8" spread="9.8"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="332"/>
                    <count group_id="B2" value="331"/>
                    <count group_id="B3" value="663"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="153"/>
                    <measurement group_id="B2" value="154"/>
                    <measurement group_id="B3" value="307"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="179"/>
                    <measurement group_id="B2" value="177"/>
                    <measurement group_id="B3" value="356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <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="332"/>
                    <count group_id="B2" value="331"/>
                    <count group_id="B3" value="663"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="285"/>
                    <measurement group_id="B2" value="282"/>
                    <measurement group_id="B3" value="567"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <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="332"/>
                    <count group_id="B2" value="331"/>
                    <count group_id="B3" value="663"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="163"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="242"/>
                    <measurement group_id="B2" value="246"/>
                    <measurement group_id="B3" value="488"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline High Resolution Computed Tomography (HRCT) fibrotic pattern</title>
          <description>HRCT fibrotic pattern, i.e. imaging pattern of the lung disease on high-resolution computed tomography assessed by central review. HRCT fibrotic pattern had two categories: 'Usual Interstitial Pneumonia (UIP)-like fibrotic pattern only', 'Other fibrotic patterns'.</description>
          <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="332"/>
                    <count group_id="B2" value="331"/>
                    <count group_id="B3" value="663"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>UIP-like fibrotic pattern only</title>
                  <measurement_list>
                    <measurement group_id="B1" value="206"/>
                    <measurement group_id="B2" value="206"/>
                    <measurement group_id="B3" value="412"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other fibrotic patterns</title>
                  <measurement_list>
                    <measurement group_id="B1" value="126"/>
                    <measurement group_id="B2" value="125"/>
                    <measurement group_id="B3" value="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Forced Vital Capacity (FVC) - Overall Population</title>
          <description>FVC is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
          <units>Milliliter (mL)</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="332"/>
                    <count group_id="B2" value="331"/>
                    <count group_id="B3" value="663"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2340.07" spread="740.19"/>
                    <measurement group_id="B2" value="2321.15" spread="727.97"/>
                    <measurement group_id="B3" value="2330.62" spread="733.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline FVC - Participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only</title>
          <description>FVC is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible.</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
          <units>Milliliter (mL)</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="206"/>
                    <count group_id="B2" value="206"/>
                    <count group_id="B3" value="412"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2363.43" spread="762.89"/>
                    <measurement group_id="B2" value="2373.59" spread="720.05"/>
                    <measurement group_id="B3" value="2368.51" spread="740.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Annual Rate of Decline in Forced Vital Capacity - Overall Population</title>
        <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Overall population consists of all randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only or HRCT fibrotic pattern= Other fibrotic patterns. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in the overall population is based on a random coefficient regression with fixed effects for treatment, HRCT fibrotic pattern, and baseline FVC [mL], and including treatment-by-time and baseline-by-time interactions. Within-participant errors are modelled by an unstructured variance-covariance matrix.</description>
        <time_frame>Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Rate of Decline in Forced Vital Capacity - Overall Population</title>
          <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Overall population consists of all randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only or HRCT fibrotic pattern= Other fibrotic patterns. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in the overall population is based on a random coefficient regression with fixed effects for treatment, HRCT fibrotic pattern, and baseline FVC [mL], and including treatment-by-time and baseline-by-time interactions. Within-participant errors are modelled by an unstructured variance-covariance matrix.</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
          <units>Milliliter per year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="332"/>
                <count group_id="O2" value="331"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-80.82" lower_limit="-110.42" upper_limit="-51.22"/>
                    <measurement group_id="O2" value="-187.78" lower_limit="-216.92" upper_limit="-158.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Fixed effects: Treatment, HRCT fibrotic pattern, baseline FVC (mL), treatment-by-time, baseline-by-time interactions.&#xD;
Random effects: time, intercept.</method_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>106.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>21.15</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>65.42</ci_lower_limit>
            <ci_upper_limit>148.50</ci_upper_limit>
            <estimate_desc>Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only is based on a random coefficient regression with fixed effects for treatment, baseline FVC [mL], and including treatment-by-time and baseline-by-time interactions. Within-participant errors are modelled by an unstructured variance-covariance matrix.</description>
        <time_frame>Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only is based on a random coefficient regression with fixed effects for treatment, baseline FVC [mL], and including treatment-by-time and baseline-by-time interactions. Within-participant errors are modelled by an unstructured variance-covariance matrix.</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
          <units>Milliliter per year</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-82.87" lower_limit="-123.73" upper_limit="-42.02"/>
                    <measurement group_id="O2" value="-211.07" lower_limit="-251.38" upper_limit="-170.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The decrease in FVC was assumed to be linear within each participant over 52 weeks. The intercepts and slopes were assumed to be normally distributed with unstructured covariance matrix. The within participant error was assumed to be independent and normally distributed with mean 0 and a common variance. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors (SEs).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <p_value_desc>Treatment comparison of slopes was assessed through the treatment-by-time interaction coefficient. P-value was not adjusted for multiple comparisons.</p_value_desc>
            <method>Mixed Models Analysis</method>
            <method_desc>Fixed effects: Treatment, baseline FVC (mL), treatment-by-time, baseline-by-time interactions. Random effects: time, intercept.</method_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>128.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>29.17</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>70.81</ci_lower_limit>
            <ci_upper_limit>185.59</ci_upper_limit>
            <estimate_desc>Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 52 - Overall Population</title>
        <description>King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were &gt;50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population was based on a Mixed Model Repeated Measures (MMRM), with fixed effects for baseline K-BILD Total score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interactions and random effect for participant. Visit was the repeated measure. Within-participant errors were modelled by unstructured variance-covariance matrix.</description>
        <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 52 - Overall Population</title>
          <description>King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were &gt;50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population was based on a Mixed Model Repeated Measures (MMRM), with fixed effects for baseline K-BILD Total score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interactions and random effect for participant. Visit was the repeated measure. Within-participant errors were modelled by unstructured variance-covariance matrix.</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
          <units>Unit on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="332"/>
                <count group_id="O2" value="330"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" lower_limit="-0.62" upper_limit="1.72"/>
                    <measurement group_id="O2" value="-0.79" lower_limit="-1.94" upper_limit="0.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <p_value>0.1115</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <method_desc>Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.</method_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>1.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.84</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.31</ci_lower_limit>
            <ci_upper_limit>2.98</ci_upper_limit>
            <estimate_desc>Adjusted mean difference was calculated as Nintedanib - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were &gt;50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only was based on a Mixed Model Repeated Measures (MMRM), with fixed effects for baseline K-BILD Total score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interactions and random effect for participant. Visit was the repeated measure. Within-participant errors were modelled by unstructured variance-covariance matrix.</description>
        <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication and who contributed to the model evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were &gt;50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only was based on a Mixed Model Repeated Measures (MMRM), with fixed effects for baseline K-BILD Total score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interactions and random effect for participant. Visit was the repeated measure. Within-participant errors were modelled by unstructured variance-covariance matrix.</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication and who contributed to the model evaluation.</population>
          <units>Unit on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
                <count group_id="O2" value="205"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.75" lower_limit="-0.82" upper_limit="2.31"/>
                    <measurement group_id="O2" value="-0.78" lower_limit="-2.34" upper_limit="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <p_value>0.1747</p_value>
            <method>Mixed Model Repeated Measures (MMRM)</method>
            <method_desc>Fixed effects: baseline K-BILD Total score, visit, treatment-by-visit and baseline-by-visit interactions, random effect: participant.</method_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>1.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.12</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.68</ci_lower_limit>
            <ci_upper_limit>3.74</ci_upper_limit>
            <estimate_desc>Adjusted mean difference was calculated as Nintedanib - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Overall Population</title>
        <description>Time to first acute ILD exacerbation or death over 52 weeks was defined as time to first acute ILD exacerbation or death due to any cause within the first 52 weeks and was computed as earliest of date of first documented acute ILD exacerbation or death - date of first drug intake + 1. Participants alive who did not experience any ILD exacerbation event or with unknown status within the first 52 weeks were censored.</description>
        <time_frame>From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Overall Population</title>
          <description>Time to first acute ILD exacerbation or death over 52 weeks was defined as time to first acute ILD exacerbation or death due to any cause within the first 52 weeks and was computed as earliest of date of first documented acute ILD exacerbation or death - date of first drug intake + 1. Participants alive who did not experience any ILD exacerbation event or with unknown status within the first 52 weeks were censored.</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="332"/>
                <count group_id="O2" value="331"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <p_value>0.3948</p_value>
            <method>Log Rank</method>
            <method_desc>Stratified by HRCT fibrotic pattern.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.80</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.48</ci_lower_limit>
            <ci_upper_limit>1.34</ci_upper_limit>
            <estimate_desc>A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Time to first acute ILD exacerbation or death over 52 weeks was defined as time to first acute ILD exacerbation or death due to any cause within the first 52 weeks and was computed as earliest of date of first documented acute ILD exacerbation or death - date of first drug intake + 1. Participants alive who did not experience any ILD exacerbation event or with unknown status within the first 52 weeks were censored.</description>
        <time_frame>From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Time to first acute ILD exacerbation or death over 52 weeks was defined as time to first acute ILD exacerbation or death due to any cause within the first 52 weeks and was computed as earliest of date of first documented acute ILD exacerbation or death - date of first drug intake + 1. Participants alive who did not experience any ILD exacerbation event or with unknown status within the first 52 weeks were censored.</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <p_value>0.1985</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>1.24</ci_upper_limit>
            <estimate_desc>A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death Over 52 Weeks - Overall Population</title>
        <description>Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause) within the first 52 weeks. Participants with no event (death from any cause) or unknown status within the first 52 weeks were censored.</description>
        <time_frame>From first drug intake until date of death or last contact date, up to 372 days</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death Over 52 Weeks - Overall Population</title>
          <description>Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause) within the first 52 weeks. Participants with no event (death from any cause) or unknown status within the first 52 weeks were censored.</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="332"/>
                <count group_id="O2" value="331"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <p_value>0.8544</p_value>
            <method>Log Rank</method>
            <method_desc>Stratified by HRCT fibrotic pattern.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>1.86</ci_upper_limit>
            <estimate_desc>A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause) within the first 52 weeks. Participants with no event (death from any cause) or unknown status within the first 52 weeks were censored.</description>
        <time_frame>From first drug intake until date of death or last contact date, up to 372 days</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause) within the first 52 weeks. Participants with no event (death from any cause) or unknown status within the first 52 weeks were censored.</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <p_value>0.3291</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
            <estimate_desc>A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death Due to Respiratory Cause Over 52 Weeks - Overall Population</title>
        <description>Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes (determined by an independent Adjudication Committee) for participants with known date of death (from respiratory causes) within the first 52 weeks. Participants with no event (death from respiratory causes) or unknown status within the first 52 weeks were censored. As less than 4.95% of the total of participants in the analysis population experienced an event, only descriptive statistics were performed, as pre-specified.</description>
        <time_frame>From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death Due to Respiratory Cause Over 52 Weeks - Overall Population</title>
          <description>Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes (determined by an independent Adjudication Committee) for participants with known date of death (from respiratory causes) within the first 52 weeks. Participants with no event (death from respiratory causes) or unknown status within the first 52 weeks were censored. As less than 4.95% of the total of participants in the analysis population experienced an event, only descriptive statistics were performed, as pre-specified.</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="332"/>
                <count group_id="O2" value="331"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death Due to Respiratory Cause Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes (determined by an independent Adjudication Committee) for participants with known date of death (from respiratory causes) within the first 52 weeks. Participants with no event (death from respiratory causes) or unknown status within the first 52 weeks were censored. As less than 4.95% of the total of participants in the analysis population experienced an event, only descriptive statistics were performed, as pre-specified.</description>
        <time_frame>From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death Due to Respiratory Cause Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes (determined by an independent Adjudication Committee) for participants with known date of death (from respiratory causes) within the first 52 weeks. Participants with no event (death from respiratory causes) or unknown status within the first 52 weeks were censored. As less than 4.95% of the total of participants in the analysis population experienced an event, only descriptive statistics were performed, as pre-specified.</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Non-calculable because the 25 percentile was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Progression or Death Over 52 Weeks - Overall Population</title>
        <description>Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Participants with no event (progression or death from any cause) or unknown status were censored. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occured for the first time. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent.</description>
        <time_frame>From first drug intake until date of progression or date of death or last contact date, up to 372 days</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Progression or Death Over 52 Weeks - Overall Population</title>
          <description>Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Participants with no event (progression or death from any cause) or unknown status were censored. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occured for the first time. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent.</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="332"/>
                <count group_id="O2" value="331"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="367" upper_limit="NA">Non-calculable because the 50 percentile was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="269" upper_limit="NA">Non-calculable because the 50 percentile was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <p_value>0.0017</p_value>
            <method>Log Rank</method>
            <method_desc>Stratified by HRCT fibrotic pattern.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>0.85</ci_upper_limit>
            <estimate_desc>A Cox proportional hazards model, stratified by HRCT fibrotic pattern, was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Progression or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Participants with no event (progression or death from any cause) or unknown status were censored. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occured for the first time. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent.</description>
        <time_frame>From first drug intake until date of progression or date of death or last contact date, up to 372 days</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Progression or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Participants with no event (progression or death from any cause) or unknown status were censored. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occured for the first time. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent.</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="206"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="365" upper_limit="NA">Non-calculable because the 50 percentile was not reached.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="254" upper_limit="NA">Non-calculable because the 50 percentile was not reached.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <p_value>0.0081</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>0.89</ci_upper_limit>
            <estimate_desc>A Cox proportional hazards model was used to estimate the hazard ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Overall Population</title>
        <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 10% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 10% and those participants with missing data (worst case analysis).</description>
        <time_frame>Baseline and up to 52 weeks after first drug intake</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Overall Population</title>
          <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 10% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 10% and those participants with missing data (worst case analysis).</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</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="332"/>
                <count group_id="O2" value="331"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.7"/>
                    <measurement group_id="O2" value="48.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>0.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.52</ci_lower_limit>
            <ci_upper_limit>0.96</ci_upper_limit>
            <estimate_desc>Ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 10% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 10% and those participants with missing data (worst case analysis).</description>
        <time_frame>Baseline and up to 52 weeks after first drug intake</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 10% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 10% and those participants with missing data (worst case analysis).</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</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="206"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3"/>
                    <measurement group_id="O2" value="52.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
            <estimate_desc>Ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Overall Population</title>
        <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 5% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 5% and those participants with missing data (worst case analysis).</description>
        <time_frame>Baseline and up to 52 weeks after first drug intake</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Overall Population</title>
          <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 5% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 5% and those participants with missing data (worst case analysis).</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication.</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="332"/>
                <count group_id="O2" value="331"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4"/>
                    <measurement group_id="O2" value="68.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>0.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>0.68</ci_upper_limit>
            <estimate_desc>Ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 5% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 5% and those participants with missing data (worst case analysis).</description>
        <time_frame>Baseline and up to 52 weeks after first drug intake</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 5% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 5% and those participants with missing data (worst case analysis).</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication.</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="206"/>
                <count group_id="O2" value="206"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.4"/>
                    <measurement group_id="O2" value="70.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <param_type>Adjusted Odds Ratio</param_type>
            <param_value>0.46</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
            <estimate_desc>Ratio calculated as Nintedanib divided by Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 - Overall Population</title>
        <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
        <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 - Overall Population</title>
          <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
          <units>Unit on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="329"/>
                <count group_id="O2" value="323"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.28" lower_limit="2.43" upper_limit="6.14"/>
                    <measurement group_id="O2" value="7.81" lower_limit="5.97" upper_limit="9.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-3.53</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.33</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.14</ci_lower_limit>
            <ci_upper_limit>-0.92</ci_upper_limit>
            <estimate_desc>Adjusted mean difference was calculated as Nintedanib - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in L-PF Symptoms Dyspnea Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
        <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in L-PF Symptoms Dyspnea Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
          <units>Unit on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="204"/>
                <count group_id="O2" value="201"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.14" lower_limit="1.81" upper_limit="6.47"/>
                    <measurement group_id="O2" value="8.32" lower_limit="5.99" upper_limit="10.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-4.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.68</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.48</ci_lower_limit>
            <ci_upper_limit>-0.88</ci_upper_limit>
            <estimate_desc>Adjusted mean difference was calculated as Nintedanib - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in L-PF Symptoms Cough Domain Score at Week 52 - Overall Population</title>
        <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
        <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
        <population>All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in L-PF Symptoms Cough Domain Score at Week 52 - Overall Population</title>
          <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
          <population>All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
          <units>Unit on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="327"/>
                <count group_id="O2" value="320"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.84" lower_limit="-4.36" upper_limit="0.69"/>
                    <measurement group_id="O2" value="4.25" lower_limit="1.74" upper_limit="6.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-6.09</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.81</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.65</ci_lower_limit>
            <ci_upper_limit>-2.53</ci_upper_limit>
            <estimate_desc>Adjusted mean difference was calculated as Nintedanib - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
        <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
        <time_frame>Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)</time_frame>
        <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
        <group_list>
          <group group_id="O1">
            <title>150 mg Nintedanib</title>
            <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
          </group>
        </group_list>
        <measure>
          <title>Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only</title>
          <description>Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).</description>
          <population>All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication and contributed to the model evaluation.</population>
          <units>Unit on scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="203"/>
                <count group_id="O2" value="199"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.20" lower_limit="-6.43" upper_limit="0.04"/>
                    <measurement group_id="O2" value="4.09" lower_limit="0.85" upper_limit="7.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>No formal hypotheses were tested.</non_inferiority_desc>
            <param_type>Adjusted mean difference</param_type>
            <param_value>-7.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.33</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.86</ci_lower_limit>
            <ci_upper_limit>-2.71</ci_upper_limit>
            <estimate_desc>Adjusted mean difference was calculated as Nintedanib - Placebo.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Treatment period plus 28 days (residual effect period), up to 836 days. Time frame for All-Cause-Mortality: Treatment period plus Follow-up, up to 900 days.</time_frame>
      <desc>All participants who signed the informed consent.</desc>
      <group_list>
        <group group_id="E1">
          <title>Nintedanib</title>
          <description>150 milligram (mg) Nintedanib as soft gelatine capsule, administered orally, twice daily (bid), with optional dose reduction to 100 mg bid to manage adverse events (AEs). Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>150 mg Nintedanib matching placebo, soft gelatine capsule, administered orally, bid, with optional dose reduction to 100 mg bid to manage AEs. Continuous daily dosing over a 52-week treatment period (Part A). After completion of the 52-week treatment period, participants continued on blinded treatment until the end of the trial or until a reason for treatment withdrawal was met (Part B).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</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="36" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="147" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="164" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood loss anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Disseminated intravascular coagulation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </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="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Atrial thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cardiac failure chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Chronic right ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cor pulmonale acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Long QT syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Prinzmetal angina</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Systolic anterior motion of mitral valve</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Deafness unilateral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Mixed deafness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Amaurosis fugax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Retinal artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Retinal vascular thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Colitis ischaemic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Enterocolitis haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Rectal prolapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Condition aggravated</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Sudden cardiac death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Adenovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Encephalitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Gastroenteritis norovirus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Herpes zoster oticus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Leishmaniasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Meningitis aseptic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Metapneumovirus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Orchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumococcal infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumonia legionella</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumonia viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pseudomembranous colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pulmonary sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Staphylococcal sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Coronary artery restenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Spinal compression fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Thoracic vertebral fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Electrocardiogram Q wave abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Rotavirus test positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </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="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hypervolaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Connective tissue disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Lumbar spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Polymyositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Scleroderma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Sjogren's syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Spinal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Systemic lupus erythematosus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Systemic scleroderma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Winged scapula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Bowen's disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Bronchial carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Gallbladder adenocarcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hepatic cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hepatocellular carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Lung squamous cell carcinoma metastatic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Lymphangiosis carcinomatosa</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Neoplasm malignant</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Salivary gland adenoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Skin cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Small cell lung cancer</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Transitional cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Dementia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hypokinesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Drug abuse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </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="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Chronic respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Eosinophilic pneumonia chronic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hypersensitivity pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Idiopathic interstitial pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumomediastinum</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pneumothorax spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pulmonary arterial hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Henoch-Schonlein purpura</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pyoderma gangrenosum</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic aneurysm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Aortic aneurysm rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Arteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Diabetic vascular disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Peripheral artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.0</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="308" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="266" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="239" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="85" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="100" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="64" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="34" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="47" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="41" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="331"/>
              </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="54" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="331"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="331"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="332"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="331"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.</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/NCT02999178
org study id: 1199.247
secondary id: 2015-003360-37
nct id: NCT02999178
lead sponsor: 
has dmc: Yes
The aim of the current study is to investigate the efficacy and safety of nintedanib over 52
      weeks in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) defined as
      patients who present with features of diffuse fibrosing lung disease of >10% extent on
      high-resolution computed tomography (HRCT) and whose lung function and respiratory symptoms
      or chest imaging have worsened despite treatment with unapproved medications used in clinical
      practice to treat ILD. There is currently no efficacious treatment available for PF-ILD.
      Based on its efficacy and safety in Idiopathic Pulmonary Fibrosis (IPF), it is anticipated
      that Nintedanib will be a new treatment option for patients with PF-ILD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Annual Rate of Decline in Forced Vital Capacity - Overall Population
time frame: Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)
description: Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Overall population consists of all randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only or HRCT fibrotic pattern= Other fibrotic patterns. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in the overall population is based on a random coefficient regression with fixed effects for treatment, HRCT fibrotic pattern, and baseline FVC [mL], and including treatment-by-time and baseline-by-time interactions. Within-participant errors are modelled by an unstructured variance-covariance matrix.
measure: Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)
description: Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Annual rate of decline in Forced Vital Capacity in milliliter (mL) per year in participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only is based on a random coefficient regression with fixed effects for treatment, baseline FVC [mL], and including treatment-by-time and baseline-by-time interactions. Within-participant errors are modelled by an unstructured variance-covariance matrix.
measure: Absolute Change From Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 52 - Overall Population
time frame: Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)
description: King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were >50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in the overall population was based on a Mixed Model Repeated Measures (MMRM), with fixed effects for baseline K-BILD Total score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interactions and random effect for participant. Visit was the repeated measure. Within-participant errors were modelled by unstructured variance-covariance matrix.
measure: Absolute Change From Baseline in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Total Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)
description: King's Brief Interstitial Lung Disease questionnaire (K-BILD) consists of 15 items and 3 domains: breathlessness and activities, psychological, and chest symptoms. Possible score ranges from 0-100, score of 100 representing the best health status. If missing items were >50% per domain, the domain score was set to missing. If any of the domain scores were missing, the total score was set to missing. Absolute change from baseline in K-BILD Total score at week 52 in participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only was based on a Mixed Model Repeated Measures (MMRM), with fixed effects for baseline K-BILD Total score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline-by-visit interactions and random effect for participant. Visit was the repeated measure. Within-participant errors were modelled by unstructured variance-covariance matrix.
measure: Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Overall Population
time frame: From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days
description: Time to first acute ILD exacerbation or death over 52 weeks was defined as time to first acute ILD exacerbation or death due to any cause within the first 52 weeks and was computed as earliest of date of first documented acute ILD exacerbation or death - date of first drug intake + 1. Participants alive who did not experience any ILD exacerbation event or with unknown status within the first 52 weeks were censored.
measure: Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days
description: Time to first acute ILD exacerbation or death over 52 weeks was defined as time to first acute ILD exacerbation or death due to any cause within the first 52 weeks and was computed as earliest of date of first documented acute ILD exacerbation or death - date of first drug intake + 1. Participants alive who did not experience any ILD exacerbation event or with unknown status within the first 52 weeks were censored.
measure: Time to Death Over 52 Weeks - Overall Population
time frame: From first drug intake until date of death or last contact date, up to 372 days
description: Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause) within the first 52 weeks. Participants with no event (death from any cause) or unknown status within the first 52 weeks were censored.
measure: Time to Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: From first drug intake until date of death or last contact date, up to 372 days
description: Time to death over 52 weeks defined as the time from date of first drug intake until date of death from any cause for participants with known date of death (from any cause) within the first 52 weeks. Participants with no event (death from any cause) or unknown status within the first 52 weeks were censored.
measure: Time to Death Due to Respiratory Cause Over 52 Weeks - Overall Population
time frame: From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days
description: Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes (determined by an independent Adjudication Committee) for participants with known date of death (from respiratory causes) within the first 52 weeks. Participants with no event (death from respiratory causes) or unknown status within the first 52 weeks were censored. As less than 4.95% of the total of participants in the analysis population experienced an event, only descriptive statistics were performed, as pre-specified.
measure: Time to Death Due to Respiratory Cause Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days
description: Time to death due to respiratory cause over 52 weeks is defined as the time from date of first drug intake until date of death attributed to respiratory causes (determined by an independent Adjudication Committee) for participants with known date of death (from respiratory causes) within the first 52 weeks. Participants with no event (death from respiratory causes) or unknown status within the first 52 weeks were censored. As less than 4.95% of the total of participants in the analysis population experienced an event, only descriptive statistics were performed, as pre-specified.
measure: Time to Progression or Death Over 52 Weeks - Overall Population
time frame: From first drug intake until date of progression or date of death or last contact date, up to 372 days
description: Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Participants with no event (progression or death from any cause) or unknown status were censored. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occured for the first time. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent.
measure: Time to Progression or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: From first drug intake until date of progression or date of death or last contact date, up to 372 days
description: Time to progression or death over 52 weeks is defined as the time from date of first drug intake to date of progression, or date of death (from any cause) if a participant died earlier. Participants with no event (progression or death from any cause) or unknown status were censored. Date of progression is defined as the date when ≥ 10% of absolute decline in FVC percent predicted compared to baseline occured for the first time. Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent.
measure: Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Overall Population
time frame: Baseline and up to 52 weeks after first drug intake
description: Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 10% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 10% and those participants with missing data (worst case analysis).
measure: Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: Baseline and up to 52 weeks after first drug intake
description: Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 10% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 10% and those participants with missing data (worst case analysis).
measure: Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Overall Population
time frame: Baseline and up to 52 weeks after first drug intake
description: Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 5% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 5% and those participants with missing data (worst case analysis).
measure: Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: Baseline and up to 52 weeks after first drug intake
description: Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Predicted normal values of FVC were calculated according to the Global Lung Initiative. FVC percent predicted (FVC % pred) is the FVC divided by its predicted value in percent. Participants with relative decline from baseline in FVC % pred greater than 5% at week 52 were those participants with a negative relative change from baseline in FVC % pred at week 52 the absolute value of which being greater than 5% and those participants with missing data (worst case analysis).
measure: Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 - Overall Population
time frame: Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)
description: Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).
measure: Absolute Change From Baseline in L-PF Symptoms Dyspnea Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)
description: Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms dyspnea domain score (dyspnea score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in dyspnea score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline dyspnea score, visit, treatment-by-visit interaction, baseline dyspnea score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).
measure: Absolute Change From Baseline in L-PF Symptoms Cough Domain Score at Week 52 - Overall Population
time frame: Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)
description: Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, HRCT fibrotic pattern, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).
measure: Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only
time frame: Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits)
description: Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44 item questionnaire with two modules Symptoms (23 items) and Impacts (21 items) where the symptoms module yields three domain scores dyspnea, cough and fatigue as well as a total symptoms score (impacts module yields a single impacts score). L-PF Symptoms cough domain score (cough score) ranges from 0-100, the higher the score the greater the impairment. If missing items were ≥50 % within a score, then the corresponding score was set to missing. Absolute change from baseline in cough score at week 52 is based on a Mixed Model Repeated Measures, with fixed effects for baseline cough score, visit, treatment-by-visit interaction, baseline cough score-by-visit interaction and random effect for participant, visit as repeated measure. The Adjusted mean is based on all analysed participants in the model (not only participants with a baseline and measurement at week 52).
arm group label: Nintedanib
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Nintedanib
arm group label: Nintedanib
other name: OVEF
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Argentina
country: Belgium
country: Canada
country: Chile
country: China
country: France
country: Germany
country: Italy
country: Japan
country: Korea, Republic of
country: Poland
country: Russian Federation
country: Spain
country: United Kingdom
country: United States
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Interstitial
mesh term: Nintedanib
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 