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This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg bis in die (BID twice daily) on the progression of IPF measured by using High Resolution Computerized Tomography(HRCT), lung function, functional component (6MWT), biomarkers, and PRO component (PROs) with continued treatment and assessments for up to 18 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nintedanib | Experimental | 150 mg twice daily |
|
| Placebo | Placebo Comparator | twice daily dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Matching Placebo | Drug | twice daily dosing |
| |
| Nintedanib |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months | Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline. | Baseline and 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months | Relative change from baseline in HRCT QLF score at 12 months was calculated as the ratio of the QLF score at 12 months to baseline. Greater values of the QLF score represented a worse health status and hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline. Note that due to the change in study design, patients randomized to the placebo group were treated with nintedanib after completion of the first 6-month treatment period. Therefore, this new endpoint was defined to address the effect of a 6-month delayed onset of nintedanib treatment. |
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Inclusion criteria:
Exclusion criteria:
AST, ALT > 1.5 fold ULN
Bilirubin > 1.5 fold ULN
Bleeding risk:
Patients who require fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, dabigatran, heparin, hirudin), or high dose antiplatelet therapy. Exceptions: prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. enoxaparin 4000 IU s.c. per day) and prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid up to 325 mg/d, or clopidogrel at 75 mg/d, or equivalent doses of other antiplatelet therapy)
History of hemorrhagic Central Nervous System (CNS) event within 12 months
Any of the following within 3 months:
Coagulation parameters: International normalised ratio (INR) > 2, prothrombin time (PT) and partial thromboplastin time (PTT) > 150% of institutional ULN.
Planned major surgery within the next 3 months, including lung transplantation, major abdominal or major intestinal surgery.
Thrombotic risk
Current or planned usage of any investigational drug during the course of this trial
Previous treatment with nintedanib within a clinical trial in the previous 3 months and discontinuation of nintedanib study treatment due to an adverse event
Known hypersensitivity to the trial drug or its component
A disease or condition which in the opinion of investigator may put the patient at risk because of participation in this trial or limit the patient's ability to participate in this trial. Patients will be excluded if they require greater than 12L/min oxygen, are not ambulatory or require use of a walker or cane during the 6 Minute Titration Walk Test. Patients who cannot complete the 6 Minute Titration Walk Test are excluded from participation.
Alcohol or drug abuse which in the opinion of the investigator would interfere with trial participation.
Pregnant women or women who are breast feeding or of child bearing potential not using two effective methods of birth control (one barrier and one highly effective non-barrier) for at least 1 month prior to trial and/or not committing to using it until 3 months after end of treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western CT Medical Group, P.C. | Danbury | Connecticut | 06810 | United States | ||
| Clinical Research Center Sarasota Memorial Hosptial |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33902584 | Derived | Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y. |
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Patients were randomized to receive nintedanib or placebo in 1:1 ratio. After Global Amendment 1, study design was changed to exploratory, and duration of double blind, placebo-controlled part of study was reduced from 12 months to 6 months, followed by conversion of all patients to open-label nintedanib treatment for a duration of up to 18 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nintedanib | Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months. |
| FG001 | Placebo | Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
gelating capsule |
|
| Baseline and 12 Months |
| Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months | Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented. | Baseline and 6 Months |
| Relative Change in FVC From Baseline at 6 Months | Relative change in FVC from baseline at 6 months is presented. | Baseline and 6 Months |
| Categorical Change in FVC From Baseline at 6 Months | Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented. | Baseline and 6 Months |
| St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months | SGRQ total score change from baseline at 6 months is presented. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6). | Baseline and 6 Months |
| 6MWT Total Distance Walked Change From Baseline at 6 Months | Change in total distance covered in 6-minute walk test (6MWT) from baseline at 6 month is presented. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. | Baseline and 6 Months |
| University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months | University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline at 6 months is presented. Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6). | Baseline and 6 Months |
| All-cause Mortality at 6 Months | Percentage of subjects died from all causes between 0 to 6 months are presented. | 6 Months |
| Respiratory Hospitalizations at 6 Months | Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented. | 6 Months |
| Respiratory Mortality at 6 Months | Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented. | 6 Months |
| Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months | Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented. | 6 Months |
| Sarasota |
| Florida |
| 34239 |
| United States |
| Chest Medicine Clinical Services | Skokie | Illinois | 60076 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Minnesota Lung Research | Minneapolis | Minnesota | 55407 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| ID Clinical Research, LTD | Toledo | Ohio | 43608 | United States |
| The Oregon Clinic | Portland | Oregon | 97220 | United States |
| Lowcountry Lung and Crit Care | Charleston | South Carolina | 29406 | United States |
| Annette C & Harold C Simmons Transplant Institute | Dallas | Texas | 75246 | United States |
| University of Alberta Hospital (University of Alberta) | Edmonton | Alberta | T6G 2G3 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Concordia Hospital | Winnipeg | Manitoba | R2K 3S8 | Canada |
| QEII Health Sciences Centre (Dalhousie University) | Halifax | Nova Scotia | B3H 3A7 | Canada |
| St. Joseph's Healthcare Hamilton | Hamilton | Ontario | L8N 4A6 | Canada |
| CHUS Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Cukurova Universitesi Tip Fakultesi Gog. Hast. Anabilim Dali | Adana | 01330 | Turkey (Türkiye) |
| Ankara Universitesi Tip Fakultesi | Ankara | 06100 | Turkey (Türkiye) |
| Istanbul Universitesi Cerrahpasa Tip Fakultesi | Istanbul | 34098 | Turkey (Türkiye) |
| Yedikule Gog. Hst. EAH | Istanbul | 34760 | Turkey (Türkiye) |
| Sureyyapasa Gogus Hast. ve Gogus Cer. Egit. ve Aras. Has. | Istanbul | 34844 | Turkey (Türkiye) |
| Ege Universitesi T.F. | Izmir | 35100 | Turkey (Türkiye) |
| Dr.Suat Seren EAH | Izmir | 35110 | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated Set (TS) consisted of patients who were randomized to a treatment group and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Nintedanib | Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months. |
| BG001 | Placebo | Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Change From Baseline in High Resolution Computerized Tomography (HRCT) Quantitative Lung Fibrosis (QLF) Score at 6 Months | Relative change from baseline in HRCT QLF score at 6 months was calculated as the difference of the QLF score at month 6 minus the QLF score at baseline divided by the baseline QLF score. The QLF score itself ranges from 0 to 100%, where greater values represent a greater amount of lung fibrosis and are considered a worse health status. Hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline. | Observed Cases (6 months) (OC6): The OC6 consisted of all patients in the TS (all patients who were randomized to a treatment group and received at least 1 dose of study drug) with observed data for the primary endpoint (relative change from baseline in HRCT QLF score at 6 months). | Posted | Least Squares Mean | Standard Error | percent change | Baseline and 6 Months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effect of Six Month Delayed Treatment Onset: Relative Change From Baseline in HRCT QLF Score at 12 Months | Relative change from baseline in HRCT QLF score at 12 months was calculated as the ratio of the QLF score at 12 months to baseline. Greater values of the QLF score represented a worse health status and hence smaller relative changes from baseline (i.e., ratios) were considered favorable. HCRT assessment obtained during screening visit was considered as baseline. Note that due to the change in study design, patients randomized to the placebo group were treated with nintedanib after completion of the first 6-month treatment period. Therefore, this new endpoint was defined to address the effect of a 6-month delayed onset of nintedanib treatment. | Observed Cases (12 months) (OC12): The OC12 consisted of all patients in OC6 with observed QLF data at 12 months. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and 12 Months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Absolute Change in Forced Vital Capacity (FVC) From Baseline at 6 Months | Absolute change in Forced Vital Capacity (FVC) from baseline at 6 months is presented. | Treated Set (TS) (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | milliliter (mL) | Baseline and 6 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Relative Change in FVC From Baseline at 6 Months | Relative change in FVC from baseline at 6 months is presented. | TS (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | percentage of change | Baseline and 6 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Categorical Change in FVC From Baseline at 6 Months | Percentage of participants reporting categorical change in FVC from baseline at 6 months are presented. | TS (Only patients with observed cases (OC) values were analysed) | Posted | Number | Percentage of participants | Baseline and 6 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | St. George's Respiratory Questionnaire (SGRQ) Total Score Change From Baseline at 6 Months | SGRQ total score change from baseline at 6 months is presented. SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. Means provided are the adjusted means based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6). | TS (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and 6 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 6MWT Total Distance Walked Change From Baseline at 6 Months | Change in total distance covered in 6-minute walk test (6MWT) from baseline at 6 month is presented. The 6-Minutes Walk Test (6-MWT) was conducted according to the American Thoracic Society (ATS) Criteria. | TS (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | meters | Baseline and 6 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) Change From Baseline at 6 Months | University of California San Diego Shortness of Breath Questionnaire (UCSD-SOBQ) change from baseline at 6 months is presented. Shortness of Breath Questionnaire measures the shortness of breath. It comprises of 24 items. Each item is scored on a scale between 0-5 where 5 represents maximal breathlessness. The responses to all items are summed up to provide the overall score that can range from 0 (best outcome) to 120 (worst outcome). Means presented are the adjusted means and are based on all analyzed patients in the model (not only patients with a baseline and measurement at month 6). | TS (Only patients with observed cases (OC) values were analysed) | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline and 6 Months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | All-cause Mortality at 6 Months | Percentage of subjects died from all causes between 0 to 6 months are presented. | TS | Posted | Number | Percentage of participants | 6 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Respiratory Hospitalizations at 6 Months | Percentage of subjects hospitalized due to respiratory problems between 0 to 6 months are presented. | TS | Posted | Number | Percentage of participants | 6 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Respiratory Mortality at 6 Months | Percentage of subjects who died due to respiratory cause between 0 to 6 months are presented. | TS | Posted | Number | Percentage of participants | 6 Months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbations at 6 Months | Percentage of subjects experienced first acute IPF exacerbations (based on Investigator reported adverse events) between 0 to 6 months are presented. | TS | Posted | Number | Percentage of participants | 6 Months |
|
|
From first drug administration till 28 days after end of treatment; up to 19 months
Treated Set
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 | Patients received oral administration of 150 milligram (mg) soft gelatin capsules of nintedanib (Ofev ®) twice daily for up to 18 months. | 11 | 56 | 54 | 56 | ||
| EG001 | Placebo | Patients receive oral administration of matching placebo of 150 mg nintedanib twice daily for a period of at least 6 months after randomization | 14 | 57 | 51 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiogenic shock | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lyme disease | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Benign neoplasm of adrenal gland | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Prothrombin time prolonged | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
This study was an exploratory trial that was not statistically powered to demonstrate significant differences between treatment groups for the efficacy endpoints evaluated.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
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