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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003360-37 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nintedanib | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Annual Rate of Decline in Forced Vital Capacity - Overall Population | 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. | Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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. | Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Change From Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 52 - Overall Population | 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. |
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Inclusion criteria:
Written Informed Consent consistent with International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice (ICH-GCP) and local laws signed prior to entry into the study (and prior to any study procedure including shipment of High Resolution Computer Tomography (HRCT) to reviewer).
Male or female patients aged >= 18 years at Visit 1.
Patients with physician diagnosed Interstitial Lung Disease (ILD) who fulfil at least one of the following criteria for Progressive Fibrosing Interstitial Lung Disease (PF-ILD) within 24 months of screening visit (Visit 1) despite treatment with unapproved medications used in clinical practice to treat ILD, as assessed by the investigator (refer to Exclusion Criteria):
Fibrosing lung disease on HRCT, defined as reticular abnormality with traction bronchiectasis with or without honeycombing, with disease extent of >10%, performed within 12 months of Visit 1 as confirmed by central readers.
For patients with underlying Connective Tissue Disease (CTD): stable CTD as defined by no initiation of new therapy or withdrawal of therapy for CTD within 6 weeks prior to Visit 1.
Carbon Monoxide Diffusion Capacity (DLCO) corrected for Haemoglobin (Hb) [visit 1] ≥ 30% and <80% predicted of normal at Visit 2
FVC >= 45% predicted at Visit 2
Exclusion criteria:
Note: Patients whose Rheumatoid Arthritis (RA)/Connective Tissue Disease (CTD) is managed by these medications should not be considered for participation in the current study unless change in RA/CTD medication is medically indicated (see Inclusion Criteria)
Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on American Thoracic Society (ATS)/ European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) 2011 Guidelines.
Significant Pulmonary Arterial Hypertension (PAH) defined by any of the following:
Major extrapulmonary physiological restriction (e.g. chest wall abnormality, large pleural effusion)
Cardiovascular diseases, any of the following:
Bleeding risk, any of the following:
Known genetic predisposition to bleeding.
Patients who require
History of haemorrhagic central nervous system (CNS) event within 12 months of Visit 1.
Any of the following within 3 months of Visit 1:
Coagulation parameters: International normalized ratio (INR) >2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by >1.5 x ULN at Visit 1.
History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Visit 1.
Known hypersensitivity to the trial medication or its components (i.e. soya lecithin)
Patients with peanut allergy.
Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
Life expectancy for disease other than ILD < 2.5 years (Investigator assessment).
Planned major surgical procedures.
Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Women of childbearing potential* not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly as well as one barrier method for 28 days prior to and 3 months after nintedanib administration. A list of contraception methods meeting these criteria is provided in the patient information.
In the opinion of the Investigator, active alcohol or drug abuse.
Patients not able to understand or follow trial procedures including completion of self-administered questionnaires without help. *A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Cedars-Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42084658 | Derived | Walters SH, Soulard S, Ye W, Elsen A, Kongnakorn T, Raj SS, Pimple P, Ferreira PG, Froidure A. Cost-Effectiveness of Earlier Diagnosis of Fibrotic Interstitial Lung Diseases (Fibrotic ILDs) and Earlier Treatment of Its Progressive Form, Progressive Pulmonary Fibrosis (PPF). Adv Ther. 2026 Jul;43(7):3134-3147. doi: 10.1007/s12325-026-03601-8. Epub 2026 May 5. | |
| 37751022 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 150 mg Nintedanib | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 8, 2018 | Apr 21, 2020 |
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| Drug |
|
| Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| 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 | 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. | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Overall Population | 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. | From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days |
| 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 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. | From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days |
| Time to Death Over 52 Weeks - Overall Population | 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. | From first drug intake until date of death or last contact date, up to 372 days |
| Time to Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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. | From first drug intake until date of death or last contact date, up to 372 days |
| Time to Death Due to Respiratory Cause Over 52 Weeks - Overall Population | 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. | From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days |
| Time to Death Due to Respiratory Cause Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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. | From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days |
| Time to Progression or Death Over 52 Weeks - Overall Population | 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. | From first drug intake until date of progression or date of death or last contact date, up to 372 days |
| Time to Progression or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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. | From first drug intake until date of progression or date of death or last contact date, up to 372 days |
| Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Overall Population | 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). | Baseline and up to 52 weeks after first drug intake |
| 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 | 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). | Baseline and up to 52 weeks after first drug intake |
| Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Overall Population | 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). | Baseline and up to 52 weeks after first drug intake |
| 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 | 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). | Baseline and up to 52 weeks after first drug intake |
| Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 - Overall Population | 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). | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| Absolute Change From Baseline in L-PF Symptoms Dyspnea Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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). | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| Absolute Change From Baseline in L-PF Symptoms Cough Domain Score at Week 52 - Overall Population | 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). | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| 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 | 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). | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| Los Angeles |
| California |
| 90048 |
| United States |
| University of California Los Angeles | Los Angeles | California | 90095 | United States |
| University of California Davis | Sacramento | California | 95817 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| National Jewish Health | Denver | Colorado | 80206 | United States |
| Pulmonary and Sleep Specialists | Danbury | Connecticut | 06810 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | United States |
| Pulmonary and Sleep of Tampa Bay | Brandon | Florida | 33511 | United States |
| University of Florida College of Medicine | Jacksonville | Florida | 32209 | United States |
| University of Miami | Miami | Florida | 33125 | United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60153 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky Medical Center | Lexington | Kentucky | 40536 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | United States |
| Pulmonary and Critical Care Associates of Baltimore | Towson | Maryland | 21286 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Pulmonary and Critical Care Medicine | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49546 | United States |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | United States |
| The Lung Research Center, LLC | Chesterfield | Missouri | 63017 | United States |
| Creighton University | Omaha | Nebraska | 68124 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | United States |
| NewYork-Presbyterian/Weill Cornell Medical Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| The Oregon Clinic | Portland | Oregon | 97220 | United States |
| The Oregon Clinic | Portland | Oregon | 97225 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Temple University Hospital | Oaks | Pennsylvania | 19456 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of South Carolina | Columbia | South Carolina | 29203 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Texas Pul & Crit Care Conslt | Fort Worth | Texas | 76104 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Medical Arts and Research Center (MARC) | San Antonio | Texas | 78229 | United States |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | United States |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | United States |
| Pulmonary Associates of Richmond, Inc. | Richmond | Virginia | 23225 | United States |
| Centro Dr. Lazaro Langer S.R.L | Alberdi Sur | X5003DCE | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | C.a.b.a | 1056 | Argentina |
| Sanatorio Güemes | Ciudad Autónoma de Bs As | C1180AAX | Argentina |
| CEMER-Centro Medico De Enfermedades Respiratorias | Florida | B1602DQD | Argentina |
| INSARES | Mendoza | M5500CCG | Argentina |
| Instituto Médico de la Fundación Estudios ClÃnicos | Rosario | S2000DEJ | Argentina |
| Centre Hospitalier Universitaire de Liège | Angleur | 4031 | Belgium |
| ULB Hopital Erasme | Brussels | 1070 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Yvoir - UNIV UCL de Mont-Godinne | Yvoir | 5530 | Belgium |
| Concordia Hospital | Winnipeg | Manitoba | R2K 3S8 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| CHUS Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Hospital ClÃnico Reg. de Concepción "Dr. G. Grant Benavente" | Concepción | 4070038 | Chile |
| Instituto Nacional del Tórax | Providencia, Santiago de Chile | 7500000 | Chile |
| Centro de Investigación del Maule | Talca | 3465586 | Chile |
| Peking Union Medical College Hospital | Beijing | 100032 | China |
| First Affiliated Hospital of Guangzhou Medical University | Guangzhou | 510120 | China |
| Nanjing Drum Tower Hospital | Nanjing | 210008 | China |
| The First Hospital of Chinese Medical University | Shenyang | China |
| HOP Avicenne | Bobigny | 93009 | France |
| HOP Louis Pradel | Bron | 69500 | France |
| HOP Côte de Nacre | Caen | 14033 | France |
| HOP d'Instruction des Armées Percy | Clamart | 92140 | France |
| HOP Calmette | Lille | 59037 | France |
| HOP Nord | Marseille | 13015 | France |
| HOP Arnaud de Villeneuve | Montpellier | 34295 | France |
| HOP Pasteur | Nice | 06001 | France |
| HOP Bichat | Paris | 75018 | France |
| HOP Maison Blanche | Reims | 51092 | France |
| HOP Pontchaillou | Rennes | 35033 | France |
| HOP Civil | Strasbourg | 67091 | France |
| HOP Bretonneau | Tours | 37000 | France |
| Universitätsklinikum Bonn AöR | Bonn | 53105 | Germany |
| Fachkrankenhaus Coswig GmbH | Coswig | 01640 | Germany |
| Klinik Donaustauf | Donaustauf | 93093 | Germany |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | 45239 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg | 69126 | Germany |
| Wissenschaftliches Institut Bethanien | Solingen | 42699 | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Petrus-Krankenhaus | Wuppertal | 42283 | Germany |
| A.O.U. Policlinico Vittorio Emanuele | Catania | 95124 | Italy |
| Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli | Forlì | 47121 | Italy |
| Azienda Ospedaliera Policlinico di Modena | Modena | 41100 | Italy |
| A.O. San Gerardo di Monza | Monza | 20900 | Italy |
| Policlinico Gemelli | Roma | 00168 | Italy |
| A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | 53100 | Italy |
| Tosei General Hospital | Aichi, Seto | 489-8642 | Japan |
| Kurume University Hospital | Fukuoka, Kurume | 830-0011 | Japan |
| Sapporo Medical University Hospital | Hokkaido, Sapporo | 060-8543 | Japan |
| National Hospital Organization Himeji Medical Center | Hyogo, Himeji | 670-8520 | Japan |
| Kobe City Medical Center General Hospital | Hyogo, Kobe | 650-0047 | Japan |
| Ibarakihigashi National Hospial | Ibaraki, Naka-gun | 319-1113 | Japan |
| Kanagawa Cardiovascular and Respiratory Center | Kanagawa, Yokohama | 236-0051 | Japan |
| Saiseikai Kumamoto Hospital | Kumamoto, Kumamoto | 861-4193 | Japan |
| Tohoku University Hospital | Miyagi, Sendai | 980-8574 | Japan |
| Nagasaki University Hospital | Nagasaki, Nagasaki | 852-8501 | Japan |
| National Hospital Organization Kinki-Chuo Chest Medical Center | Osaka, Sakai | 591-8555 | Japan |
| Osaka Medical College Hospital | Osaka, Takatsuki | 569-8686 | Japan |
| Hamamatsu University Hospital | Shizuoka, Hamamatsu | 431-3192 | Japan |
| Jichi Medical University Hospital | Tochigi, Shimotsuke | 329-0498 | Japan |
| Tokushima University Hospital | Tokushima, Tokushima | 770-8503 | Japan |
| Tokyo Medical and Dental University | Tokyo, Bunkyo-ku | 113-8519 | Japan |
| Nippon Medical School Hospital | Tokyo, Bunkyo-ku | 113-8603 | Japan |
| Toranomon Hospital | Tokyo, Minato-ku | 105-8470 | Japan |
| JR Tokyo General Hospital | Tokyo, Shibuya-ku | 151-8528 | Japan |
| Global Health and Medicine Ctr | Tokyo, Shinjuku-ku | 162-8655 | Japan |
| University Clinical Center, Gdansk | Gdansk | 80-214 | Poland |
| Leszek Giec Upper-Silesian Med.Cent.Silesian Med.Univ. | Katowice | 40-752 | Poland |
| Norbert Barlicki University Clinical Hospital No.1, Lodz | Lodz | 90-153 | Poland |
| Nat.Instit.of Tuberculosis&LungDiseases,Outpat.Clin,warszawa | Warsaw | 01-138 | Poland |
| Clinical Hospital No. 1, n.a. Prof. Szyszko from Silesian MA | Zabrze | 41-803 | Poland |
| Res.Inst.-Compl.Iss.Cardi.Dis. | Kemerovo | 650002 | Russia |
| Pulmonology Scientific Research Institute | Moscow | 105077 | Russia |
| Central Scientific Research Insitute of Tuberculosis | Moscow | 107564 | Russia |
| Moscow 1st State Med.Univ.n.a.I.M.Sechenov | Moscow | 119992 | Russia |
| Scientific Research Institute of Pulmonology | Saint Petersburg | 197101 | Russia |
| Emergency Clinical Hospital n. a. N. V. Solovyev, Yaroslavl | Yaroslavl | 150003 | Russia |
| The Catholic University of Korea, Bucheon St.Mary's Hospital | Bucheon-si | 14647 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Hospital Santa Creu i Sant Pau | Barcelona | 08026 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital de Galdakao | Galdakao | 48960 | Spain |
| Hospital de Bellvitge | L'Hospitalet de Llobregat | 08907 | Spain |
| Hospital La Princesa | Madrid | 28006 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Hospital Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Son Espases | Palma de Mallorca | 07120 | Spain |
| Hospital de Canarias | San Cristóbal de La Laguna | 38320 | Spain |
| Hospital Virgen del RocÃo | Seville | 41013 | Spain |
| Hospital Politècnic La Fe | Valencia | 46026 | Spain |
| University Hospital Llandough | Cardiff | CF64 2XX | United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
| Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |
| Royal Stoke University Hospital | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Kolb M, Flaherty KR, Silva RS, Prasse A, Vancheri C, Mueller H, Sroka-Saidi K, Wells AU; INBUILD trial investigators. Effect of Nintedanib in Patients with Progressive Pulmonary Fibrosis in Subgroups with Differing Baseline Characteristics. Adv Ther. 2023 Dec;40(12):5536-5546. doi: 10.1007/s12325-023-02668-x. Epub 2023 Sep 26. |
| 36894966 | Derived | Kreuter M, Bendstrup E, Jouneau S, Maher TM, Inoue Y, Miede C, Lievens D, Crestani B. Weight loss and outcomes in subjects with progressive pulmonary fibrosis: data from the INBUILD trial. Respir Res. 2023 Mar 9;24(1):71. doi: 10.1186/s12931-023-02371-z. |
| 36642509 | Derived | Inoue Y, Wells AU, Song JW, Xu Z, Kitamura H, Suda T, Okamoto M, Muller H, Coeck C, Rohr KB, Kolb M, Brown KK. Nintedanib in Asian patients with progressive fibrosing interstitial lung diseases: Results from the INBUILD trial. Respirology. 2023 May;28(5):465-474. doi: 10.1111/resp.14452. Epub 2023 Jan 15. |
| 35927208 | Derived | Ogura T, Suda T, Inase N, Nishioka Y, Azuma A, Okamoto M, Takizawa A, Ito T, Rohr KB, Inoue Y. Effects of nintedanib on disease progression and safety in Japanese patients with progressive fibrosing interstitial lung diseases: Further subset analysis from the whole INBUILD trial. Respir Investig. 2022 Nov;60(6):787-797. doi: 10.1016/j.resinv.2022.06.009. Epub 2022 Aug 1. |
| 35392908 | Derived | Cottin V, Martinez FJ, Jenkins RG, Belperio JA, Kitamura H, Molina-Molina M, Tschoepe I, Coeck C, Lievens D, Costabel U. Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial. Respir Res. 2022 Apr 7;23(1):85. doi: 10.1186/s12931-022-01974-2. |
| 35241434 | Derived | Swigris JJ, Bushnell DM, Rohr K, Mueller H, Baldwin M, Inoue Y. Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores in patients with progressive fibrosing interstitial lung diseases. BMJ Open Respir Res. 2022 Mar;9(1):e001167. doi: 10.1136/bmjresp-2021-001167. |
| 34564020 | Derived | Inoue Y, Suda T, Kitamura H, Okamoto M, Azuma A, Inase N, Kuwana M, Makino S, Nishioka Y, Ogura T, Takizawa A, Ugai H, Stowasser S, Schlenker-Herceg R, Takeuchi T. Efficacy and safety of nintedanib in Japanese patients with progressive fibrosing interstitial lung diseases: Subgroup analysis of the randomised, double-blind, placebo-controlled, phase 3 INBUILD trial. Respir Med. 2021 Oct;187:106574. doi: 10.1016/j.rmed.2021.106574. Epub 2021 Aug 12. |
| 34475231 | Derived | Flaherty KR, Wells AU, Cottin V, Devaraj A, Inoue Y, Richeldi L, Walsh SLF, Kolb M, Koschel D, Moua T, Stowasser S, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in progressive interstitial lung diseases: data from the whole INBUILD trial. Eur Respir J. 2022 Mar 17;59(3):2004538. doi: 10.1183/13993003.04538-2020. Print 2022 Mar. |
| 34210788 | Derived | Maher TM, Brown KK, Kreuter M, Devaraj A, Walsh SLF, Lancaster LH, Belloli EA, Padilla M, Behr J, Goeldner RG, Tetzlaff K, Schlenker-Herceg R, Flaherty KR; INBUILD trial investigators. Effects of nintedanib by inclusion criteria for progression of interstitial lung disease. Eur Respir J. 2022 Feb 3;59(2):2004587. doi: 10.1183/13993003.04587-2020. Print 2022 Feb. |
| 33726766 | Derived | Cottin V, Richeldi L, Rosas I, Otaola M, Song JW, Tomassetti S, Wijsenbeek M, Schmitz M, Coeck C, Stowasser S, Schlenker-Herceg R, Kolb M; INBUILD Trial Investigators. Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. Respir Res. 2021 Mar 16;22(1):84. doi: 10.1186/s12931-021-01668-1. |
| 32217654 | Derived | Brown KK, Martinez FJ, Walsh SLF, Thannickal VJ, Prasse A, Schlenker-Herceg R, Goeldner RG, Clerisme-Beaty E, Tetzlaff K, Cottin V, Wells AU. The natural history of progressive fibrosing interstitial lung diseases. Eur Respir J. 2020 Jun 25;55(6):2000085. doi: 10.1183/13993003.00085-2020. Print 2020 Jun. |
| 32145830 | Derived | Wells AU, Flaherty KR, Brown KK, Inoue Y, Devaraj A, Richeldi L, Moua T, Crestani B, Wuyts WA, Stowasser S, Quaresma M, Goeldner RG, Schlenker-Herceg R, Kolb M; INBUILD trial investigators. Nintedanib in patients with progressive fibrosing interstitial lung diseases-subgroup analyses by interstitial lung disease diagnosis in the INBUILD trial: a randomised, double-blind, placebo-controlled, parallel-group trial. Lancet Respir Med. 2020 May;8(5):453-460. doi: 10.1016/S2213-2600(20)30036-9. Epub 2020 Mar 5. |
| 31566307 | Derived | Flaherty KR, Wells AU, Cottin V, Devaraj A, Walsh SLF, Inoue Y, Richeldi L, Kolb M, Tetzlaff K, Stowasser S, Coeck C, Clerisme-Beaty E, Rosenstock B, Quaresma M, Haeufel T, Goeldner RG, Schlenker-Herceg R, Brown KK; INBUILD Trial Investigators. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. N Engl J Med. 2019 Oct 31;381(18):1718-1727. doi: 10.1056/NEJMoa1908681. Epub 2019 Sep 29. |
| 29018526 | Derived | Flaherty KR, Brown KK, Wells AU, Clerisme-Beaty E, Collard HR, Cottin V, Devaraj A, Inoue Y, Le Maulf F, Richeldi L, Schmidt H, Walsh S, Mezzanotte W, Schlenker-Herceg R. Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease. BMJ Open Respir Res. 2017 Sep 17;4(1):e000212. doi: 10.1136/bmjresp-2017-000212. eCollection 2017. |
| FG001 | Placebo | 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). |
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| NOT COMPLETED |
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Treated set: This set included all randomized participants who received at least 1 dose of trial medication.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 150 mg Nintedanib | 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). |
| BG001 | Placebo | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline High Resolution Computed Tomography (HRCT) fibrotic pattern | 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'. | Count of Participants | Participants |
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| Baseline Forced Vital Capacity (FVC) - Overall Population | FVC is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. | Mean | Standard Deviation | Milliliter (mL) |
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| Baseline FVC - Participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only | FVC is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. | All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication. | Mean | Standard Deviation | Milliliter (mL) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Annual Rate of Decline in Forced Vital Capacity - Overall Population | 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. | All randomized participants in the overall population who received at least 1 dose of trial medication. | Posted | Least Squares Mean | 95% Confidence Interval | Milliliter per year | Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
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| Primary | Annual Rate of Decline in Forced Vital Capacity - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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. | All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication. | Posted | Least Squares Mean | 95% Confidence Interval | Milliliter per year | Baseline, 2, 4, 6, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
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| Secondary | Absolute Change From Baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) Total Score at Week 52 - Overall Population | 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. | All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
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| Secondary | 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 | 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
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| Secondary | Time to First Acute Interstitial Lung Disease (ILD) Exacerbation or Death Over 52 Weeks - Overall Population | 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. | All randomized participants in the overall population who received at least 1 dose of trial medication. | Posted | Median | Inter-Quartile Range | Days | From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days |
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| Secondary | 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 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. | All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication. | Posted | Median | Inter-Quartile Range | Days | From first drug intake until date of first acute ILD exacerbation or date of death or last contact date, up to 372 days |
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| Secondary | Time to Death Over 52 Weeks - Overall Population | 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. | All randomized participants in the overall population who received at least 1 dose of trial medication. | Posted | Median | Inter-Quartile Range | Days | From first drug intake until date of death or last contact date, up to 372 days |
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| Secondary | Time to Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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. | All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication. | Posted | Median | Inter-Quartile Range | Days | From first drug intake until date of death or last contact date, up to 372 days |
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| Secondary | Time to Death Due to Respiratory Cause Over 52 Weeks - Overall Population | 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. | All randomized participants in the overall population who received at least 1 dose of trial medication. | Posted | Median | Inter-Quartile Range | Days | From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days |
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| Secondary | Time to Death Due to Respiratory Cause Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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. | All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication. | Posted | Median | Inter-Quartile Range | Days | From date of first trial drug intake up to date of death from respiratory causes or last contact date, up to 372 days |
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| Secondary | Time to Progression or Death Over 52 Weeks - Overall Population | 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. | All randomized participants in the overall population who received at least 1 dose of trial medication. | Posted | Median | Inter-Quartile Range | Days | From first drug intake until date of progression or date of death or last contact date, up to 372 days |
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| Secondary | Time to Progression or Death Over 52 Weeks - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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. | All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication. | Posted | Median | Inter-Quartile Range | Days | From first drug intake until date of progression or date of death or last contact date, up to 372 days |
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| Secondary | Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 10 Percent at Week 52 - Overall Population | 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). | All randomized participants in the overall population who received at least 1 dose of trial medication. | Posted | Number | Percentage of participants | Baseline and up to 52 weeks after first drug intake |
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| Secondary | 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 | 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). | All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication. | Posted | Number | Percentage of participants | Baseline and up to 52 weeks after first drug intake |
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| Secondary | Percentage of Participants With a Relative Decline From Baseline in FVC Percent Predicted of More Than 5 Percent at Week 52 - Overall Population | 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). | All randomized participants in the overall population who received at least 1 dose of trial medication. | Posted | Number | Percentage of participants | Baseline and up to 52 weeks after first drug intake |
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| Secondary | 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 | 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). | All randomized participants with HRCT fibrotic pattern=UIP-like fibrotic pattern only who received at least 1 dose of trial medication. | Posted | Number | Percentage of participants | Baseline and up to 52 weeks after first drug intake |
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| Secondary | Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52 - Overall Population | 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). | All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in L-PF Symptoms Dyspnea Domain Score at Week 52 - Participants With HRCT Fibrotic Pattern=UIP-like Fibrotic Pattern Only | 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). | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change From Baseline in L-PF Symptoms Cough Domain Score at Week 52 - Overall Population | 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). | All randomized participants in the overall population who received at least 1 dose of trial medication and contributed to the model evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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). | 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. | Posted | Least Squares Mean | 95% Confidence Interval | Unit on scale | Baseline, 12, 24, 36, 52 weeks after first drug intake (planned post-baseline visits) |
|
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.
All participants who signed the informed consent.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nintedanib | 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). | 36 | 332 | 147 | 332 | 308 | 332 |
| EG001 | Placebo | 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). | 45 | 331 | 164 | 331 | 266 | 331 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial thrombosis | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chronic right ventricular failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cor pulmonale acute | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Long QT syndrome | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Systolic anterior motion of mitral valve | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mixed deafness | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Amaurosis fugax | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Retinal vascular thrombosis | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Enterocolitis haemorrhagic | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rectal prolapse | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Discomfort | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Herpes zoster oticus | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Leishmaniasis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Metapneumovirus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumococcal infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary artery restenosis | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Electrocardiogram Q wave abnormal | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Rotavirus test positive | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Polymyositis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sjogren's syndrome | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Systemic scleroderma | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Winged scapula | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Gallbladder adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Lung squamous cell carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphangiosis carcinomatosa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Salivary gland adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Skin cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebellar infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anxiety disorder | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Glomerulonephritis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Eosinophilic pneumonia chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypersensitivity pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Idiopathic interstitial pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary arterial hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arteritis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diabetic vascular disorder | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2018 | Apr 21, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
Not provided
Not provided
Not provided
|
|
|
|
|
|
Difference of adjusted annual rates of decline was calculated as Nintedanib - Placebo. |
| Superiority |
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).
|
|
|
| OG001 | Placebo | 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). |
|
|
|
| OG001 | Placebo | 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). |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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).
|
|
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). |
|
|
|
| OG001 |
| Placebo |
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). |
|
|
|
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).
|
|
|
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). |
|
|
|
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).
|
|
|
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). |
|
|
|
| OG001 | Placebo | 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). |
|
|
|
| OG001 | Placebo | 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). |
|
|
|
| OG001 | Placebo | 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). |
|
|
|
| OG001 | Placebo | 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). |
|
|
|