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The purpose of the present study is to evaluate the characteristics, management and clinical course of patients with IPF as treated under real-world in Italian Pulmonary Centres, in terms of symptoms, lung function and exercise tolerance during 12 months of observation.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With IPF Symptoms | Percentage of participants with IPF symptoms such as cough, fatigue, dizziness, chest pain or any other symptom at 12-month follow up visit. The symptoms in the class 'other' reported upon specific visits were dyspnea, hemoptysis, post-nasal drip, sputum, weight loss, worsening of fatigue and lack of appetite. Baseline (V1), 3 months (V2), 6 months (V3), 9 months (V4) and 12 months (V5). | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity | In calculating the change from baseline to all follow-up visits (3 months, 6 months, 9 months and 12 months) in lung function: Vital Capacity (VC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter VC = value of parameter VC at follow up visit - value of parameter VC at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) | In calculating the change from baseline to follow-up visits in lung function: Forced Vital Capacity (FVC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter FVC = value of parameter FVC at follow up visit - value of parameter FVC at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) | In calculating the change from baseline to follow-up visits in lung function: Forced Vital Capacity (FVC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter FVC = value of parameter FVC at follow up visit - value of parameter FVC at baseline visit. A positive value of change indicates a better outcome. The value of FVC % of predicted is a relevant parameter to understand and classify the severity of the disease at the diagnosis and to follow up patients during the treatment (i.e. annual rate decline of FVC >10% is a predictor of high rate of mortality). |
| Measure | Description | Time Frame |
|---|---|---|
| Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age | IPF enrolled participants were described in terms of socio-demographic variables (e.g. age, gender, race, body mass index, educational degree, and employment status) at baseline. | Baseline |
| Characteristic of Participants at Enrollment: Key Demographic Data: Gender |
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Inclusion criteria:
Patients aged>=40 years
Written informed consent to both participation in the study and privacy
Physician diagnosed IPF during the last 3 months based upon recent American Thoracic Society/European Resp. Society/Japanese Resp. Society/Latin American Thoracic Association guidelines 2011 (see Tables A1-A2 for High Resolution Chest Computer Tomography and histology criteria):
Patient with further follow-up possible with enrolling investigator during planned study period
Patients capable of discernment and able to read or write in Italian language.
Exclusion criteria:
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IPF pts
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O.U. Policlinico Vittorio Emanuele | Catania | 95124 | Italy | |||
| Osp. Clin. SS. Anunziata |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33627105 | Derived | Poletti V, Vancheri C, Albera C, Harari S, Pesci A, Metella RR, Campolo B, Crespi G, Rizzoli S; FIBRONET study group. Clinical course of IPF in Italian patients during 12 months of observation: results from the FIBRONET observational study. Respir Res. 2021 Feb 24;22(1):66. doi: 10.1186/s12931-021-01643-w. |
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Data source for this study were medical records usually collected during routine clinical practice other than study-specific questionnaires.
This was an observational study based on participants newly diagnosed with Idiopathic Pulmonary Fibrosis (IPF) for less than 3 months, who enrolled in 20 Italian Pulmonary Centers highly experienced in the disease management of IPF. Data collection was performed between 30th November 2015 and 15th May 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Idiopathic Pulmonary Fibrosis | Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Idiopathic Pulmonary Fibrosis | Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Participants With IPF Symptoms | Percentage of participants with IPF symptoms such as cough, fatigue, dizziness, chest pain or any other symptom at 12-month follow up visit. The symptoms in the class 'other' reported upon specific visits were dyspnea, hemoptysis, post-nasal drip, sputum, weight loss, worsening of fatigue and lack of appetite. Baseline (V1), 3 months (V2), 6 months (V3), 9 months (V4) and 12 months (V5). | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Number | Percentage of participants | Baseline, 3 months, 6 months, 9 months and 12 months |
|
For serious adverse event (SAE) and Non-SAE: From IPF diagnosis until the end of observation period, up to 12 months. For All-cause mortality: From signing informed consent until the end of observation period, up to 493 days.
All patients who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Idiopathic Pulmonary Fibrosis | Participants with Idiopathic Pulmonary Fibrosis (IPF) as treated under real-world in Italian Pulmonary Centers, were enrolled between 30th November 2015 to 6th April 2017, followed by an observational phase of 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2018 | May 16, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 26, 2015 | May 16, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second | In calculating the change from baseline to follow-up visits in lung function: Forced Expiratory Volume in the 1st second (FEV1), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter FEV1 = value of parameter FEV1 at follow up visit - value of parameter FEV1 at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity | In calculating the change from baseline to follow-up visits in lung function: Total Lung Capacity (TLC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter TLC = value of parameter TLC at follow up visit - value of parameter TLC at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide | In calculating the change from baseline to follow-up visits in lung function: Diffusion capacity for carbon monoxide (DLCO), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter DLCO = value of parameter DLCO at follow up visit - value of parameter DLCO at baseline visit. A positive value of change indicates a better outcome. Values of DLCO with unit = milliliter/minute/millimeter mercury (ml/min/mmHg) were converted to micromole/minute/kilopascal (mmol/min/kPa) according to the following formula: DLCO (mmol/min/kPa) = DLCO (ml/min/mmHg)/2.986 [46]. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen | In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Oxygen (PO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter PO2 = value of parameter PO2 at follow up visit - value of parameter PO2 at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide | In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Carbon dioxide (PCO2), only patients with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter PCO2 = value of parameter PCO2 at follow up visit - value of parameter PCO2 at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation | In calculating the change from baseline to follow-up visits in lung function: Oxygen Saturation (SaO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter SaO2 = value of parameter SaO2 at follow up visit - value of parameter SaO2 at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest | In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Oxygen in arterial blood at rest (PaO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter PaO2 = value of parameter PaO2 at follow up visit - value of parameter PaO2 at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest | In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Carbon dioxide in arterial blood at rest (PaCO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter PaCO2 = value of parameter PaCO2 at follow up visit - value of parameter PaCO2 at baseline visit. A positive value of change indicates a better outcome. | Baseline, 3 months, 6 months, 9 months and 12 months |
| Change From Baseline to Follow-up Visits in Exercise Tolerance | Change from baseline to follow-up visits in exercise tolerance was evaluated by means of change in 6 minute walked distance test. Change versus baseline was calculated as parameter at follow up - parameter at baseline. A positive value of change indicates a better outcome. The 6-minute walked distance test was carried out using two parameters start of peripheral capillary oxygen saturation (SpO2) and SpO2 at the end of the test. Only participants with values available at baseline and at follow up were considered | Baseline, 3 months, 6 months, 9 months and 12 months |
IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their gender are presented. The data is provided in baseline section. |
| Baseline |
| Characteristic of Participants at Enrollment: Key Demographic Data: Race | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their race are presented. The data is provided in baseline section. | Baseline |
| Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their highest education level. | Baseline |
| Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their employment status are presented. | Baseline |
| Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their Body mass index are presented. | Baseline |
| Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their housing situation are presented. | Baseline |
| Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their marital status are presented. | Baseline |
| IPF Risk Factors: Smoking Habit | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their smoking habits are presented. | Baseline |
| IPF Risk Factors: Environmental Exposure | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their environmental exposure (such as bricklayer, building material dust, cement dust, chemical gas, coal dust, factory food, marble dust, masonry dust, mold, paint, powdered detergent and textile material) are presented. | Baseline |
| IPF Risk Factors: Exposure to Drugs Associated With IPF | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their exposure to drugs associated with IPF are presented. | Baseline |
| IPF Risk Factors: Family History | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their family history for IPF are presented. | Baseline |
| Number of Participants With Comorbidity | Number of participants with ongoing comorbidities (such as gastroesophageal reflux disease, pulmonary hypertension, emphysema, lung cancer, coronary heart disease, depression) are provided. Some participants reported more than one comorbidity at enrollment. | Baseline |
| IPF Disease Severity and Manifestation | IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values) is measured by the FVC. Percentages are calculated out of the total number of evaluable participants with available FVC of the predicted at baseline. | Baseline |
| Number of Participants With Different Methods Used for IPF Diagnosis | Several diagnostic approaches were used to detect IPF, the main ones being High Resolution chest Computer Tomography (HRCT), surgical lung biopsy, Bronchoalveolar lavage (BAL), transbronchial biopsy and spirometry. | Baseline |
| IPF Treatment Modalities: Non-pharmacological Treatment | Number of participants with ≥1 non-pharmacological therapy for IPF ongoing at baseline (visit 1), 3-month (visit 2), 6-month (visit 3) and 12-month (visit 5) follow up visits are presented. | Baseline, 3 months, 6 months and 12 months |
| IPF Treatment Modalities: Lung Transplantation | Number of participants who had lung transplantation at baseline, 3-month, 6-month and 12-month follow up visits are presented. | Baseline, 3 months, 6 months and 12 months |
| IPF Treatment Modalities: Prescribed Drugs and Dose | IPF Patients with ≥1 pharmacological therapy for IPF ongoing at baseline, 3-month, 6-month and 12-month follow up visits are presented. The pharmacological therapies used for IPF treatment are Nintedanib and Pirfenidone. | Baseline, 3 months, 6 months and 12 months |
| Number of Exacerbations During 12 Months of Observation | Number of participants with mild, moderate and severe exacerbations during the observation period are presented. An exacerbation was considered occurred during observation period if onset date ≥ date of first IPF diagnosis and onset date ≤ last available visit date (for participants who completed the study) or date of drop out or date of death (for participants who did not complete the study). | Up to 12 months |
| Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire | Health Related Quality of Life (HRQoL) variation measured with Saint George's Respiratory Questionnaire (SGRQ), developed to measure health in chronic airflow limitation. It is a disease-specific instrument designed to measure health impairment in terms of impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. Three component scores (symptoms, activity and impacts on daily life) and a total score were calculated, with lower scores corresponding to better health. The Total score is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. | Baseline, 6 months and 12 months |
| HRQoL Variation Measured With EuroQol Descriptive System | The quality of life was evaluated by the EuroQol 5-dimension 5-level (EQ-5D-5L) a standardized measure of health status developed by EuroQol Group to provide a simple generic measure of health status for clinical and economic evaluation. EQ-5D-5L was filled in by participants, it was easy from a cognitive point of view, since it took only few minutes for filling. EQ-5D-5L consists of 2 sections: "EQ-5D descriptive system" and EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | Baseline, 6 months and 12 months |
| HRQoL Measured With EQ VAS | The quality of life was evaluated by the EQ-5D-5L a standardized measure of health status developed by EuroQol Group to provide a simple generic measure of health status for clinical and economic evaluation. EQ-5D-5L consists of 2 sections: "EQ-5D descriptive system" and EQ VAS. The EQ VAS indicate the health status self-assessed by the participants on a visual analogue scale from 0 to 100, where 100 is the "best imaginable health state" and 0 the "worst imaginable health state". It can be used as a quantitative measure of health as judged by participants. | Baseline, 6 months and 12 months |
| Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS) | The health care sector-related costs at diagnosis and from diagnosis up to the end of 12-month follow-up according to the INHS point of view, was carried out in a two-step approach: (i)First of all the resource consumption exclusively related to both IPF, IPF exacerbations and IPF-related adverse events since diagnosis was collected or estimated and then (ii) A monetary value was assigned to the collected or estimated resource consumption. Health care resource consumption was computed during observational period in terms of number of (inward and day-hospital) hospitalizations and number of Intensive Care Unit (ICU) admissions. | Up to 12 months |
| Chieti |
| 66100 |
| Italy |
| Ospedale Colonnello D Avanzo | Foggia | 71100 | Italy |
| Ospedale "G.B. Morgagni - L. Pierantoni" ausl forli | Forlì | 47121 | Italy |
| Osp. S. Giuseppe Fatebenefratelli | Milan | 20123 | Italy |
| Azienda Ospedaliera Policlinico di Modena | Modena | 41124 | Italy |
| A.O. San Gerardo di Monza | Monza | 20900 | Italy |
| Azienda Ospedaliera Universitaria "Federico II" | Naples | 80138 | Italy |
| Azienda Sanitaria Ospedale S. Luigi Gonzaga | Orbassano | 10043 | Italy |
| Azienda Ospedaliera Universitaria di Padova | Padova | 35128 | Italy |
| Fondazione IRCCS Policlinico S. Matteo | Pavia | 27100 | Italy |
| Ospedale di Cisanello | Pisa | 56124 | Italy |
| Pol. Universitario Tor Vergata | Roma | 00133 | Italy |
| A.O. San Camillo Forlanini | Roma | 00149 | Italy |
| Policlinico Gemelli | Roma | 00168 | Italy |
| Policlinico Universitario di Sassari | Sassari | 07100 | Italy |
| A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | 53100 | Italy |
| Ospedale Riuniti di Ancona | Torrette-Ancona | 60126 | Italy |
| Inclusion in clinical trial |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity data were not collected from any participant. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| IPF symptoms | Number | Percentage of participants |
|
|
|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Vital Capacity | In calculating the change from baseline to all follow-up visits (3 months, 6 months, 9 months and 12 months) in lung function: Vital Capacity (VC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter VC = value of parameter VC at follow up visit - value of parameter VC at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | Liters (L) | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Actual) | In calculating the change from baseline to follow-up visits in lung function: Forced Vital Capacity (FVC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter FVC = value of parameter FVC at follow up visit - value of parameter FVC at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | L | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Forced Vital Capacity (Predicted) | In calculating the change from baseline to follow-up visits in lung function: Forced Vital Capacity (FVC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter FVC = value of parameter FVC at follow up visit - value of parameter FVC at baseline visit. A positive value of change indicates a better outcome. The value of FVC % of predicted is a relevant parameter to understand and classify the severity of the disease at the diagnosis and to follow up patients during the treatment (i.e. annual rate decline of FVC >10% is a predictor of high rate of mortality). | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | Percent Predicted | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Forced Expiratory Volume in the 1st Second | In calculating the change from baseline to follow-up visits in lung function: Forced Expiratory Volume in the 1st second (FEV1), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter FEV1 = value of parameter FEV1 at follow up visit - value of parameter FEV1 at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | L | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Total Lung Capacity | In calculating the change from baseline to follow-up visits in lung function: Total Lung Capacity (TLC), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter TLC = value of parameter TLC at follow up visit - value of parameter TLC at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | L | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Diffusion Capacity for Carbon Monoxide | In calculating the change from baseline to follow-up visits in lung function: Diffusion capacity for carbon monoxide (DLCO), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter DLCO = value of parameter DLCO at follow up visit - value of parameter DLCO at baseline visit. A positive value of change indicates a better outcome. Values of DLCO with unit = milliliter/minute/millimeter mercury (ml/min/mmHg) were converted to micromole/minute/kilopascal (mmol/min/kPa) according to the following formula: DLCO (mmol/min/kPa) = DLCO (ml/min/mmHg)/2.986 [46]. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | mmol/min/kPa | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
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| Primary | Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen | In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Oxygen (PO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter PO2 = value of parameter PO2 at follow up visit - value of parameter PO2 at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | Millimeter mercury (mmHg) | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide | In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Carbon dioxide (PCO2), only patients with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter PCO2 = value of parameter PCO2 at follow up visit - value of parameter PCO2 at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | mmHg | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Oxygen Saturation | In calculating the change from baseline to follow-up visits in lung function: Oxygen Saturation (SaO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter SaO2 = value of parameter SaO2 at follow up visit - value of parameter SaO2 at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | Percentage (%) of SaO2 | Baseline, 3 months, 6 months, 9 months and 12 months |
|
|
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| Primary | Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Oxygen in Arterial Blood at Rest | In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Oxygen in arterial blood at rest (PaO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter PaO2 = value of parameter PaO2 at follow up visit - value of parameter PaO2 at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | mmHg | Baseline, 3 months, 6 months, 9 months and 12 months |
|
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|
| Primary | Change From Baseline to Follow-up Visits in Lung Function: Partial Pressure of Carbon Dioxide in Arterial Blood at Rest | In calculating the change from baseline to follow-up visits in lung function: Partial Pressure of Carbon dioxide in arterial blood at rest (PaCO2), only participants with values available at baseline and at follow up were considered. At follow up visit the absolute changes of lung function assessment vs baseline value was calculated as: Change in parameter PaCO2 = value of parameter PaCO2 at follow up visit - value of parameter PaCO2 at baseline visit. A positive value of change indicates a better outcome. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | mmHg | Baseline, 3 months, 6 months, 9 months and 12 months |
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| Primary | Change From Baseline to Follow-up Visits in Exercise Tolerance | Change from baseline to follow-up visits in exercise tolerance was evaluated by means of change in 6 minute walked distance test. Change versus baseline was calculated as parameter at follow up - parameter at baseline. A positive value of change indicates a better outcome. The 6-minute walked distance test was carried out using two parameters start of peripheral capillary oxygen saturation (SpO2) and SpO2 at the end of the test. Only participants with values available at baseline and at follow up were considered | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | Percentage (%) of SpO2 | Baseline, 3 months, 6 months, 9 months and 12 months |
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| Secondary | Characteristic of Participants at Enrollment: Key Socio-demographic Data: Age | IPF enrolled participants were described in terms of socio-demographic variables (e.g. age, gender, race, body mass index, educational degree, and employment status) at baseline. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Mean | Standard Deviation | Years | Baseline |
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| Secondary | Characteristic of Participants at Enrollment: Key Demographic Data: Gender | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their gender are presented. The data is provided in baseline section. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | Characteristic of Participants at Enrollment: Key Demographic Data: Race | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their race are presented. The data is provided in baseline section. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | Characteristic of Participants at Enrollment: Key Demographic Data: Highest Education Level | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their highest education level. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | Characteristic of Participants at Enrollment: Key Demographic Data: Employment Status | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their employment status are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | Characteristic of IPF Patients at Enrollment: Key Demographic Data: Body Mass Index | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their Body mass index are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | Characteristic of Participants at Enrollment: Key Demographic Data: Housing Situation | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their housing situation are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | Characteristic of Participants at Enrollment: Key Demographic Data: Marital Status | IPF enrolled participants were described in terms of socio-economic variables; number of participants as per their marital status are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | IPF Risk Factors: Smoking Habit | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their smoking habits are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | IPF Risk Factors: Environmental Exposure | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their environmental exposure (such as bricklayer, building material dust, cement dust, chemical gas, coal dust, factory food, marble dust, masonry dust, mold, paint, powdered detergent and textile material) are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | IPF Risk Factors: Exposure to Drugs Associated With IPF | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their exposure to drugs associated with IPF are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | IPF Risk Factors: Family History | IPF enrolled participants were described in terms of potential IPF risk factors; number of participants as per their family history for IPF are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | Number of Participants With Comorbidity | Number of participants with ongoing comorbidities (such as gastroesophageal reflux disease, pulmonary hypertension, emphysema, lung cancer, coronary heart disease, depression) are provided. Some participants reported more than one comorbidity at enrollment. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | IPF Disease Severity and Manifestation | IPF disease severity and manifestation (including lung function, cardiopulmonary exercise testing and/or exercise capacity if available, laboratory values) is measured by the FVC. Percentages are calculated out of the total number of evaluable participants with available FVC of the predicted at baseline. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Percentage of participants | Baseline |
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| Secondary | Number of Participants With Different Methods Used for IPF Diagnosis | Several diagnostic approaches were used to detect IPF, the main ones being High Resolution chest Computer Tomography (HRCT), surgical lung biopsy, Bronchoalveolar lavage (BAL), transbronchial biopsy and spirometry. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Baseline |
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| Secondary | IPF Treatment Modalities: Non-pharmacological Treatment | Number of participants with ≥1 non-pharmacological therapy for IPF ongoing at baseline (visit 1), 3-month (visit 2), 6-month (visit 3) and 12-month (visit 5) follow up visits are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Number | Participants | Baseline, 3 months, 6 months and 12 months |
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| Secondary | IPF Treatment Modalities: Lung Transplantation | Number of participants who had lung transplantation at baseline, 3-month, 6-month and 12-month follow up visits are presented. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Number | Participants | Baseline, 3 months, 6 months and 12 months |
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| Secondary | IPF Treatment Modalities: Prescribed Drugs and Dose | IPF Patients with ≥1 pharmacological therapy for IPF ongoing at baseline, 3-month, 6-month and 12-month follow up visits are presented. The pharmacological therapies used for IPF treatment are Nintedanib and Pirfenidone. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Number | Participants | Baseline, 3 months, 6 months and 12 months |
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| Secondary | Number of Exacerbations During 12 Months of Observation | Number of participants with mild, moderate and severe exacerbations during the observation period are presented. An exacerbation was considered occurred during observation period if onset date ≥ date of first IPF diagnosis and onset date ≤ last available visit date (for participants who completed the study) or date of drop out or date of death (for participants who did not complete the study). | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. | Posted | Number | Participants | Up to 12 months |
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| Secondary | Health Related Quality of Life Variation Measured With Saint George's Respiratory Questionnaire | Health Related Quality of Life (HRQoL) variation measured with Saint George's Respiratory Questionnaire (SGRQ), developed to measure health in chronic airflow limitation. It is a disease-specific instrument designed to measure health impairment in terms of impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. Three component scores (symptoms, activity and impacts on daily life) and a total score were calculated, with lower scores corresponding to better health. The Total score is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Median | Inter-Quartile Range | Unit on scale | Baseline, 6 months and 12 months |
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| Secondary | HRQoL Variation Measured With EuroQol Descriptive System | The quality of life was evaluated by the EuroQol 5-dimension 5-level (EQ-5D-5L) a standardized measure of health status developed by EuroQol Group to provide a simple generic measure of health status for clinical and economic evaluation. EQ-5D-5L was filled in by participants, it was easy from a cognitive point of view, since it took only few minutes for filling. EQ-5D-5L consists of 2 sections: "EQ-5D descriptive system" and EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Number | Percentage (%) of participants | Baseline, 6 months and 12 months |
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| Secondary | HRQoL Measured With EQ VAS | The quality of life was evaluated by the EQ-5D-5L a standardized measure of health status developed by EuroQol Group to provide a simple generic measure of health status for clinical and economic evaluation. EQ-5D-5L consists of 2 sections: "EQ-5D descriptive system" and EQ VAS. The EQ VAS indicate the health status self-assessed by the participants on a visual analogue scale from 0 to 100, where 100 is the "best imaginable health state" and 0 the "worst imaginable health state". It can be used as a quantitative measure of health as judged by participants. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | Unit on scale | Baseline, 6 months and 12 months |
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| Secondary | Health Care Resource Consumption From Diagnosis up to End of 12 Months Follow-up According to the Italian National Health Service (INHS) | The health care sector-related costs at diagnosis and from diagnosis up to the end of 12-month follow-up according to the INHS point of view, was carried out in a two-step approach: (i)First of all the resource consumption exclusively related to both IPF, IPF exacerbations and IPF-related adverse events since diagnosis was collected or estimated and then (ii) A monetary value was assigned to the collected or estimated resource consumption. Health care resource consumption was computed during observational period in terms of number of (inward and day-hospital) hospitalizations and number of Intensive Care Unit (ICU) admissions. | All participants who enrolled in the Italian Pulmonary Centers from 30th November 2015 to 6th April 2017 were included. Participants with values available at baseline and at follow up visits were considered. | Posted | Mean | Standard Deviation | Days | Up to 12 months |
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|
| 13 |
| 209 |
| 16 |
| 209 |
| 38 |
| 209 |
| Cardiac arrest | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Death | General disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
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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.
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| V4-V1 |
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| V5-V1 |
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| V4-V1 Actual |
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|
| V5-V1 Actual |
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|
| Title | Measurements |
|---|---|
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| V5-V1 Predicted |
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| V4-V1 |
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| V5-V1 |
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|
|
| V4-V1 |
|
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| V5-V1 |
|
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|
| V4-V1 |
|
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| V5-V1 |
|
|
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| V4-V1 |
|
|
| V5-V1 |
|
|
|
| V4-V1 |
|
|
| V5-V1 |
|
|
|
| V4-V1 |
|
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| V5-V1 |
|
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| V4-V1 |
|
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| V5-V1 |
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| V4-V1 |
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| V5-V1 |
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| SpO2 at start of the test - V4-V1 |
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| SpO2 at start of the test - V5-V1 |
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| SpO2 at the end of the test - V2-V1 |
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| SpO2 at the end of the test - V3-V1 |
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| SpO2 at the end of the test - V4-V1 |
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| SpO2 at the end of the test - V5-V1 |
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| Title | Measurements |
|---|---|
|
| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| High school |
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| Academic degree |
|
| Unknown |
|
| Title | Measurements |
|---|
|
| Housewife / househusband |
|
| Unknown |
|
| Title | Measurements |
|---|---|
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| Obese |
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| Not Reported |
|
| Title | Measurements |
|---|---|
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
| Unknown |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Atrial fibrillation |
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| Benign Prostatic Hypertrophy |
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| Cerebrovascular disease (Carotid stenosis, stroke) |
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| Deep venous thrombosis |
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| Diabetes mellitus |
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| Emphysema |
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| Gastroesophageal reflux disease |
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| Hypercholesterolemia |
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| Lung cancer |
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| Peripheral arterial disease |
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| Pulmonary hypertension |
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| Renal insufficiency |
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| Other |
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| Previous myocardial infarction |
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| Title | Measurements |
|---|---|
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| FVC >=90% |
|
| Title | Measurements |
|---|---|
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| Transbronchial Biopsy |
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| Spirometry |
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| Other |
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| V2: LtOT |
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| V3: LtOT |
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| V3: LtOT-Cardiopulmonary exercise training |
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| V5: LtOT |
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| V5: LtOT-Cardiopulmonary exercise training |
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| V3 |
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| V5 |
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| V3 |
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| V5 |
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| Title | Measurements |
|---|---|
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| V5 |
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| Perform daily activies easily - V1 |
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| Not to have pain - V1 |
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| Not to be anxious - V1 |
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| Autonomous in self care - V3 |
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| Walk without difficulties - V3 |
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| Perform daily activies easily - V3 |
|
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| Not to have pain - V3 |
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| Not to be anxious - V3 |
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| Autonomous in self care - V5 |
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| Walk without difficulties - V5 |
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| Perform daily activies easily - V5 |
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| Not to have pain - V5 |
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| Not to be anxious - V5 |
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| Title | Measurements |
|---|---|
|
| Overall duration of ICU admissions |
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