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Descriptive prospective non-interventional multicenter study based on newly collected data of Idiopathic Pulmonary Fibrosis patients followed-up for one year in secondary care settings (Pulmonology Services)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis patients | all IPF patients |
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| Measure | Description | Time Frame |
|---|---|---|
| Idiopathic Pulmonary Fibrosis (IPF)-Related Costs | The total annual IPF-related costs were obtained as the sum of direct health costs, direct non-health costs and indirect costs. IPF-related costs were quantified for each patient over the follow-up period of 12 months. The direct health and direct non-health costs were calculated as the sum of the costs of medical visits, emergency room visits, hospital admissions, outpatient tests, non-pharmacological treatments and pharmacological treatments and the sum of transport costs, paid caregivers costs, orthopedic material costs, financial aid, and structural changes cost. The indirect costs included number of IPF related days off work and time dedicated to patient care with IPF (informal caregiver). The opportunity cost method was used to calculate informal care costs. The indirect costs were estimated by applying salary costs based on the latest data published by the Spanish Instituto Nacional de Estadística from the salary structure survey, adjusted to age. | 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)). |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ) | The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value, is assessed through SGRQ. The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). The number of participants analysed displays the number of participants with available data at the timepoint of interests. |
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Inclusion Criteria:
Exclusion Criteria:
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It is planned that data of approximately 200 patients from approximately 25 sites (secondary care sites - Pulmonology services where IPF is diagnosed and managed) in Spain will be collected. All Idiopathic Pulmonary Fibrosis patients who are diagnosed with IPF and attend to a routine visit during the inclusion period and fulfill inclusion/exclusion criteria and provide informed consent to participate will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Mireia Canals, +34607550925 | mireia.canals@boehringer-ingelheim.com | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain | |||
| Hospital Infanta Cristina |
All patients who are diagnosed with IPF and attended to a routine visit during the inclusion period and met all of the inclusion and none of the exclusion criteria and provided informed consent to participate were included in the study. IPF-Patients were reported by subgroup (predicted FVC% at baseline) for baseline characteristics and outcome measures, to make comparisons between groups. Data on caregiver burden was collected from routine clinical care using medical records and patient´s diary.
Non-interventional multicenter study in Spain, based on newly collected data of patients with Idiopathic Pulmonary Fibrosis (IPF) aims to estimate the economic and social Impact of IPF according to the Forced Vital Capacity (FVC) value.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients With IPF - Overall Population | All patients with Idiopathic Pulmonary Fibrosis (IPF). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Evaluable Population: All participants who meet the selection criteria (no protocol deviations) and with predicted FVC% classified (in baseline visit). IPF-patients were reported by subgroups (according to predicted FVC at baseline) to make comparisons between groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | IPF Patients With Predicted FVC <50% at T0 - Subgroup | All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0). Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Idiopathic Pulmonary Fibrosis (IPF)-Related Costs | The total annual IPF-related costs were obtained as the sum of direct health costs, direct non-health costs and indirect costs. IPF-related costs were quantified for each patient over the follow-up period of 12 months. The direct health and direct non-health costs were calculated as the sum of the costs of medical visits, emergency room visits, hospital admissions, outpatient tests, non-pharmacological treatments and pharmacological treatments and the sum of transport costs, paid caregivers costs, orthopedic material costs, financial aid, and structural changes cost. The indirect costs included number of IPF related days off work and time dedicated to patient care with IPF (informal caregiver). The opportunity cost method was used to calculate informal care costs. The indirect costs were estimated by applying salary costs based on the latest data published by the Spanish Instituto Nacional de Estadística from the salary structure survey, adjusted to age. | Evaluable Population (cost): Evaluable Population who had data on resource use due to IPF (primary/secondary care/emergency visits, transport, hospitalization, outpatient tests, (non)-pharmacological treatment, caregivers, orthopedic material, structural changes, economic aid, lost work productivity, resource use due to acute exacerbations). IPF-patients were reported by subgroup to make comparisons between groups. | Posted | Mean | Standard Deviation | Euro (€) | 12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)). |
From signing informed consent until end of study, up to 12 months.
For all-cause mortality and serious adverse events the safety population (All screened patients with informed consent prior to participation) was used. Other Adverse events were reported only for patients with at least one dose of OFEV® (OFEV® Population), as defined in the study report. Please note that the number of deaths reported in all-cause mortality is higher than reported in the participant flow due to a number of participants dying after discontinuing the study.
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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 | All Patients With IPF - Overall Population | All patients with Idiopathic Pulmonary Fibrosis (IPF). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA v22.0. | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | 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 | Oct 30, 2019 | Sep 8, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 15, 2017 | Oct 13, 2020 | Prot_002.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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| 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)). |
| Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS) | The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the EQ-VAS, which is a self-rated health status using a visual analogue scale (VAS), ranging form 0-100, with 0 = worst state of health imaginable and 100 = best state of health imaginable. The EQ-VAS is part of the EuroQoL five dimensions questionaire 5L (EQ-5D-5L). The number of participants analysed displays the number of participants with available data at the timepoint of interests. | 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)). |
| Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index | The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the Barthel Index. Barthel Index were used to score the ability of a participant to care for himself. It consists of 10 items, the values assigned to each item are based on time and amount of actual physical assistance required if a participant is unable to perform the activity. The final score ranges from 0 and 100. Participant scoring 100 is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs. The number of participants analysed displays the number of participants with available data at the timepoint of interests. | 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)). |
| Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year | Number of IPF-patients with acute exacerbations according to Forced Vital Capacity (FVC)% that occured along one year. Acute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality. | 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)). |
| Total Annual Acute Exacerbation-related Costs | The total annual acute exacerbation-related costs were obtained as the sum of direct and indirect costs for each patient over the follow-up period of 12 months. For estimation of costs the following variables were used: Acute exacerbation related resource use for direct cost estimation: primary and secondary care visits, emergency visits (primary care and hospital), hospitalizations, ICU with and without intubation (qualitative analysis), outpatient tests and other examinations, use of transport, use of formal caregiver, pharmacological and non-pharmacological treatments (except treatments administered in hospitalization), orthopedic material, formal social services, economic aid and structural adaptations. Acute exacerbation related resource use for indirect cost estimation: patients' days off work and informal caregiver. | 12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)). |
| Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group | Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0 | Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC <50% at baseline. | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0 | Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC 50-80% at baseline. | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0 | Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC > 80% at baseline. | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group | Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the Quality of Life according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0 | Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) In order to estimate SGRQ according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC<50% at baseline. | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0 | Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) Results are reported for participants with predicted FVC 50-80% at baseline. | 12 months (At baseline visit (T0) and at 12 month visit (T12)). |
| Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0 | Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) Results are reported for participants with predicted FVC >80% at baseline. | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Overall FVC Patient Group | Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0 | Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC<50% at baseline. | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Subgroup: Predicted FVC 50-80% at T0 | Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC 50-80% at baseline. | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0 | Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC>80% at baseline. | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
| Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire | Caregivers of IPF patients were asked to complete the Zarit Burden Interview. It is a self-report measure. The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options, in the Spanish version, range from 0 (never) to 4 (nearly always). The final score ranges from 0 to 88. A higher score implies a greater burden (≤ 21: Little or no burden; 22-40: mild to moderate burden; 41-60: moderate to severe burden; ≥ 61: severe burden). | 12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)). |
| Badajoz |
| 06080 |
| Spain |
| Hospital Universitario Cruces | Barakaldo (Vizcaya) | 48903 | Spain |
| H. del Mar | Barcelona | 8003 | Spain |
| H. U. Vall d'Hebron | Barcelona | 8035 | Spain |
| H. U. de Bellvitge | Barcelona | 8907 | Spain |
| H. U. Germans Trias i Pujol | Barcelona | 8916 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital General Universitario Santa Lucía | Cartagena (Murcia) | 30202 | Spain |
| Hospital General Universitario de Castellón | Castellon | 12004 | Spain |
| H. U. de Girona Doctor Josep Trueta | Girona | 17007 | Spain |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Can Misses | Ibiza Town | 7800 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | 27003 | Spain |
| H. Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | 28040 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda (Madrid) | 28222 | Spain |
| H. Son Llatzer | Mallorca | 7198 | Spain |
| H. de Manacor | Mallorca | 7500 | Spain |
| Hospital Costa del Sol | Marbella (Málaga) | 29603 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | 29010 | Spain |
| H. Mateu Orfila | Menorca | 7703 | Spain |
| Hospital Montecelo | Mourente (Pontevedra) | 36071 | Spain |
| CHU de Ourense | Ourense | 32005 | Spain |
| H. Central de Asturias | Oviedo | 33011 | Spain |
| Hospital Universitari Son Espases | Palma de Mallorca | 07020 | Spain |
| Hospital Universitario Donostia | San Sebastián | 20014 | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Sierrallana y Tres Mares | Torrelavega (Cantabria) | 39300 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Hospital Miguel Servet | Zaragoza | 50009 | Spain |
| Withdrawal by Subject |
|
| Death |
|
| BG001 | IPF Patients With Predicted FVC 50-80% at T0 - Subgroup | All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0). Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). |
| BG002 | IPF Patients With Predicted FVC >80% at T0 - Subgroup | All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0). Patient group (FVC<50%, FVC 50-80%, FVC>80%) was calculated based on available patient data: Men: FVC % predicted (%)= 100 FVC/(0.0678 T -0.0147 E -6.0548) Women: FVC % predicted (%)= 100 FVC /(0.0454 T -0.0211 E -2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
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|
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| Secondary | Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ) | The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value, is assessed through SGRQ. The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). The number of participants analysed displays the number of participants with available data at the timepoint of interests. | Evaluable Population including participants with available data for SGRQ at T0, T6 and T12. IPF-patients were reported by subgroup to make comparisons between groups. | Posted | Mean | Standard Deviation | Score on a scale | 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)). |
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| Secondary | Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS) | The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the EQ-VAS, which is a self-rated health status using a visual analogue scale (VAS), ranging form 0-100, with 0 = worst state of health imaginable and 100 = best state of health imaginable. The EQ-VAS is part of the EuroQoL five dimensions questionaire 5L (EQ-5D-5L). The number of participants analysed displays the number of participants with available data at the timepoint of interests. | Evaluable Population including participants with available data for EQ-VAS at T0, T6 and T12. IPF-patients were reported by subgroup to make comparisons between groups. | Posted | Mean | Standard Deviation | Score on a scale | 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)). |
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| Secondary | Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index | The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the Barthel Index. Barthel Index were used to score the ability of a participant to care for himself. It consists of 10 items, the values assigned to each item are based on time and amount of actual physical assistance required if a participant is unable to perform the activity. The final score ranges from 0 and 100. Participant scoring 100 is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs. The number of participants analysed displays the number of participants with available data at the timepoint of interests. | Evaluable Population including participants with available data for Barthel Index at T0, T6 and T12. IPF-patients were reported by subgroup to make comparisons between groups. | Posted | Mean | Standard Deviation | Score on a scale | 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)). |
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| Secondary | Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year | Number of IPF-patients with acute exacerbations according to Forced Vital Capacity (FVC)% that occured along one year. Acute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality. | Evaluable Population: All patients who met the selection criteria (no protocol deviations) and with predicted FVC% classified. IPF-patients were reported by subgroup to make comparisons between groups. | Posted | Number | Participants | 12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)). |
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| Secondary | Total Annual Acute Exacerbation-related Costs | The total annual acute exacerbation-related costs were obtained as the sum of direct and indirect costs for each patient over the follow-up period of 12 months. For estimation of costs the following variables were used: Acute exacerbation related resource use for direct cost estimation: primary and secondary care visits, emergency visits (primary care and hospital), hospitalizations, ICU with and without intubation (qualitative analysis), outpatient tests and other examinations, use of transport, use of formal caregiver, pharmacological and non-pharmacological treatments (except treatments administered in hospitalization), orthopedic material, formal social services, economic aid and structural adaptations. Acute exacerbation related resource use for indirect cost estimation: patients' days off work and informal caregiver. | Evaluable Population (cost): Evaluable Population who had data on resource use due to IPF (primary/secondary care/emergency visits, transport, hospitalization, outpatient tests, (non)-pharmacological treatment, caregivers, orthopedic material, structural changes, economic aid, lost work productivity, resource use due to acute exacerbations). IPF-patients were reported by subgroup to make comparisons between groups. | Posted | Mean | Standard Deviation | Euro (€) | 12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)). |
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| Secondary | Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group | Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% | Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Overall FVC Patient Group. | Posted | Mean | Standard Deviation | Euro (€) | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0 | Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: FVC predicted along the study. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC <50% at baseline. | Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup with predicted FVC <50% at T0. | Posted | Mean | Standard Deviation | Euro (€) | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0 | Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC 50-80% at baseline. | Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup predicted FVC 50-80% at T0. | Posted | Mean | Standard Deviation | Euro (€) | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0 | Economic Impact of IPF in adult patients through the estimation annual direct and indirect costs associated with the disease (€/year) from a social perspective by FVC decline according to predicted FVC%. FVC decline is calculated: FVC% (T12)- FVC%(T0)). In order to estimate the direct and indirect costs according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC > 80% at baseline. | Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup with predicted FVC >80% at T0. | Posted | Mean | Standard Deviation | Euro (€) | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group | Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the Quality of Life according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% | Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with SGRQ values at T0 and T12 - Overall FVC patient group. | Posted | Mean | Standard Deviation | Score on a scale | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0 | Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms, activity and impact. The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) In order to estimate SGRQ according to FVC decline the following variable were described: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years). The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC<50% at baseline. | Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with SGRQ values at T0 and T12 - Subgroup with predicted FVC <50% at T0. | Posted | Mean | Standard Deviation | Score on a scale | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0 | Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) Results are reported for participants with predicted FVC 50-80% at baseline. | Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with SGRQ values at T0 and T12 - Subgroup with predicted FVC 50-80% at T0. | Posted | Mean | Standard Deviation | Score on a scale | 12 months (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Absolute Change in Saint George´s Respiratory Questionaire (SGRQ) Score From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0 | Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The SGRQ is a 50-item questionaire developed to quantify the impact of the disease on the health and QoL perceived by patients with respiratory diseases. It consisted of 50 items divided into 3 scales: symptoms (frequency and severity of respiratory symptoms), activity (limitations due to dyspnoea) and impact (psychological and social functioning disorders caused by the disease). The final scores ranged from 0 (best health-related quality of life) to 100 (worse health-related quality of life). FVC decline: FVC% (T12)- FVC%(T0) Results are reported for participants with predicted FVC >80% at baseline. | Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with SGRQ values at T0 and T12 - Subgroup with predicted FVC >80% at T0. | Posted | Mean | Standard Deviation | Score on a scale | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Overall FVC Patient Group | Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% | Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with EQ-VAS values at T0 and T12 - Overall FVC Patient Group. | Posted | Mean | Standard Deviation | Score on scale | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0 | Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study: Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC<50% at baseline. | Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with EQ-VAS values at T0 and T12 - Subgroup with predicted FVC <50% at T0. | Posted | Mean | Standard Deviation | Score on scale | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline- Subgroup: Predicted FVC 50-80% at T0 | Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC 50-80% at baseline. | Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with EQ-VAS values at T0 and T12 - Subgroup with predicted FVC 50-80% at T0. | Posted | Mean | Standard Deviation | Score on scale | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Absolute Change in EuroQoL Visual Analogue Scale (EQ-VAS) From Baseline Visit (T0) to 12 Month Visit (T12) by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0 | Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12). The EQVAS is a self-rated health status using a VAS (0-100), with 0= worst state of health imaginable and 100= best state of health imaginable. The EQ-VAS records the subject's perceptions of their own current overall health. FVC decline: FVC% (T12)- FVC%(T0) In order to estimate the EQ-VAS according to FVC decline the following variable were described: FVC % predicted along the study:. Men: FVC % predicted (%) = 100 FVC / (0.0678 T - 0.0147 E - 6.0548) Women: FVC % predicted (%) = 100 FVC / (0.0454 T - 0.0211 E - 2.8253) (FVC is FVC in liters, T is height in cm and E is age in years) The calculated variable was stratified into the following subgroups between T0 and T12: ≤-10%; from -10% to -5%; >-5% Results are reported for participants with predicted FVC>80% at baseline. | Evaluable Population including participants with FVC decline between T0 and T12 (paired data) and with EQ-VAS values at T0 and T12 - Subgroup with predicted FVC >80% at T0. | Posted | Mean | Standard Deviation | Score on scale | 12 months. (At baseline visit (T0) and at 12 month visit (T12)). |
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| Secondary | Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire | Caregivers of IPF patients were asked to complete the Zarit Burden Interview. It is a self-report measure. The revised version contains 22 items. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options, in the Spanish version, range from 0 (never) to 4 (nearly always). The final score ranges from 0 to 88. A higher score implies a greater burden (≤ 21: Little or no burden; 22-40: mild to moderate burden; 41-60: moderate to severe burden; ≥ 61: severe burden). | Caregivers who have signed the specific written informed consent. | Posted | Mean | Standard Deviation | Score an a scale | 12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)). |
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| 30 |
| 204 |
| 31 |
| 204 |
| 12 |
| 89 |
| Cardiac failure congestive | Cardiac disorders | MedDRA v22.0. | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA v22.0. | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v22.0. | Systematic Assessment |
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| Asthenia | General disorders | MedDRA v22.0. | Systematic Assessment |
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| Death | General disorders | MedDRA v22.0. | Systematic Assessment |
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| Disease progression | General disorders | MedDRA v22.0. | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA v22.0. | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA v22.0. | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v22.0. | Systematic Assessment |
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| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0. | Systematic Assessment |
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| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v22.0. | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA v22.0. | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA v22.0. | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v22.0. | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0. | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0. | Systematic Assessment |
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| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0. | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0. | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v22.0. | Systematic Assessment |
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| Solid organ transplant | Surgical and medical procedures | MedDRA v22.0. | Systematic Assessment |
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Not provided
Not provided
Not provided
| Male |
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| T6 |
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| T12 |
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| 0.1385 |
| Other |
| Kruskal-Wallis | Timepoint: T12 | 0.0233 | Other |
| T6 |
|
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| T12 |
|
|
Timepoint: T6 |
| Other |
| Kruskal-Wallis | 0.2019 | Timepoint: T12 | Other |
| T6 |
|
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| T12 |
|
|
Timepoint: T6 |
| Other |
| Kruskal-Wallis | 0.4794 | Timepoint: T12 | Other |
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| Annual direct non-health IPF-related costs |
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| Annual indirect IPF-related costs |
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| 0.4095 |
| Other |
| ANOVA | Annual direct non-health IPF-related costs | 0.0435 | Other |
| ANOVA | Annual indirect IPF-related costs | 0.5479 | Other |
|
| Annual indirect IPF-related costs |
|
|
| Annual direct non-healt IPF-related costs |
|
| Annual indirect IPF-related costs |
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| 0.7652 |
| Other |
| ANOVA | Annual direct non-health IPF-related costs | 0.0037 | Other |
| ANOVA | Annual indirect IPF-related costs | 0.6119 | Other |
|
| Annual direct non-health IPF-related costs |
|
| Annual indirect IPF-related costs |
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| 0.1581 |
| Other |
| ANOVA | Annual direct non-health IPF-related costs | 0.7165 | Other |
| ANOVA | Annual indirect IPF-related costs | 1.0000 | Other |
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| T12 |
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