Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2026-01-05 @ 8:02 PM
Study NCT ID:
NCT03386994
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2017-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From signing informed consent until end of study, up to 12 months.', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'All Patients With IPF - Overall Population', 'description': 'All patients with Idiopathic Pulmonary Fibrosis (IPF).', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 204, 'otherNumAffected': 12, 'seriousNumAtRisk': 204, 'deathsNumAffected': 30, 'seriousNumAffected': 31}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}, {'term': 'Solid organ transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 204, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v22.0.'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IPF Patients With Predicted FVC <50% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG001', 'title': 'IPF Patients With Predicted FVC 50-80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG002', 'title': 'IPF Patients With Predicted FVC >80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).\n\nPatient 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).'}], 'classes': [{'title': 'Total annual IPF related costs', 'categories': [{'measurements': [{'value': '38923.57', 'spread': '29263.42', 'groupId': 'OG000'}, {'value': '22613.68', 'spread': '12873.07', 'groupId': 'OG001'}, {'value': '20369.94', 'spread': '11955.91', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct health IPF-related costs', 'categories': [{'measurements': [{'value': '37183.17', 'spread': '28465.86', 'groupId': 'OG000'}, {'value': '22425.64', 'spread': '12788.42', 'groupId': 'OG001'}, {'value': '20195.31', 'spread': '12159.89', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct non-health related costs', 'categories': [{'measurements': [{'value': '1657.63', 'spread': '3148.58', 'groupId': 'OG000'}, {'value': '149.25', 'spread': '701.58', 'groupId': 'OG001'}, {'value': '174.63', 'spread': '589.53', 'groupId': 'OG002'}]}]}, {'title': 'Annual indirect IPF-related costs', 'categories': [{'measurements': [{'value': '82.77', 'spread': '320.58', 'groupId': 'OG000'}, {'value': '38.79', 'spread': '316.50', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Total annual IPF-related costs'}, {'pValue': '0.0007', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual direct health IPF-related costs'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual direct non-health IPF-related costs'}, {'pValue': '0.6839', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual indirect IPF-related costs'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).', 'description': '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.', 'unitOfMeasure': 'Euro (€)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IPF Patients With Predicted FVC <50% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG001', 'title': 'IPF Patients With Predicted FVC 50-80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG002', 'title': 'IPF Patients With Predicted FVC >80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).\n\nPatient 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).'}], 'classes': [{'title': 'T0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '48.52', 'spread': '17.26', 'groupId': 'OG000'}, {'value': '33.70', 'spread': '17.17', 'groupId': 'OG001'}, {'value': '31.97', 'spread': '20.37', 'groupId': 'OG002'}]}]}, {'title': 'T6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '43.34', 'spread': '20.70', 'groupId': 'OG000'}, {'value': '33.84', 'spread': '19.15', 'groupId': 'OG001'}, {'value': '30.68', 'spread': '17.98', 'groupId': 'OG002'}]}]}, {'title': 'T12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.64', 'spread': '21.62', 'groupId': 'OG000'}, {'value': '36.93', 'spread': '19.27', 'groupId': 'OG001'}, {'value': '25.38', 'spread': '17.38', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Timepoint: T0'}, {'pValue': '0.1385', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Timepoint: T6'}, {'pValue': '0.0233', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Timepoint: T12'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).', 'description': '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.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IPF Patients With Predicted FVC <50% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG001', 'title': 'IPF Patients With Predicted FVC 50-80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG002', 'title': 'IPF Patients With Predicted FVC >80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).\n\nPatient 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).'}], 'classes': [{'title': 'T0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '58.41', 'spread': '16.72', 'groupId': 'OG000'}, {'value': '64.82', 'spread': '20.43', 'groupId': 'OG001'}, {'value': '66.67', 'spread': '21.39', 'groupId': 'OG002'}]}]}, {'title': 'T6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.29', 'spread': '21.11', 'groupId': 'OG000'}, {'value': '65.16', 'spread': '19.02', 'groupId': 'OG001'}, {'value': '68.76', 'spread': '19.85', 'groupId': 'OG002'}]}]}, {'title': 'T12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '63.93', 'spread': '23.95', 'groupId': 'OG000'}, {'value': '62.91', 'spread': '20.34', 'groupId': 'OG001'}, {'value': '71.36', 'spread': '17.74', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1560', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Timepoint: T0', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.3144', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Timepoint: T6', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.2019', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Timepoint: T12', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).', 'description': '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).\n\nThe number of participants analysed displays the number of participants with available data at the timepoint of interests.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IPF Patients With Predicted FVC <50% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG001', 'title': 'IPF Patients With Predicted FVC 50-80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG002', 'title': 'IPF Patients With Predicted FVC >80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).\n\nPatient 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).'}], 'classes': [{'title': 'T0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.95', 'spread': '10.76', 'groupId': 'OG000'}, {'value': '97.50', 'spread': '7.68', 'groupId': 'OG001'}, {'value': '97.67', 'spread': '5.68', 'groupId': 'OG002'}]}]}, {'title': 'T6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.25', 'spread': '12.08', 'groupId': 'OG000'}, {'value': '95.94', 'spread': '11.21', 'groupId': 'OG001'}, {'value': '96.35', 'spread': '8.19', 'groupId': 'OG002'}]}]}, {'title': 'T12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '91.79', 'spread': '15.76', 'groupId': 'OG000'}, {'value': '95.74', 'spread': '12.66', 'groupId': 'OG001'}, {'value': '96.59', 'spread': '12.85', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0075', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Timepoint: T0', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.0361', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Timepoint: T6', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.4794', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'Timepoint: T12', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).', 'description': 'The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the Barthel Index.\n\nBarthel 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.\n\nThe number of participants analysed displays the number of participants with available data at the timepoint of interests.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IPF Patients With Predicted FVC <50% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG001', 'title': 'IPF Patients With Predicted FVC 50-80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG002', 'title': 'IPF Patients With Predicted FVC >80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).\n\nPatient 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0333', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).', 'description': 'Number of IPF-patients with acute exacerbations according to Forced Vital Capacity (FVC)% that occured along one year.\n\nAcute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Total Annual Acute Exacerbation-related Costs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'IPF Patients With Predicted FVC <50% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG001', 'title': 'IPF Patients With Predicted FVC 50-80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'OG002', 'title': 'IPF Patients With Predicted FVC >80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).\n\nPatient 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).'}], 'classes': [{'categories': [{'measurements': [{'value': '600.40', 'spread': '1586.20', 'groupId': 'OG000'}, {'value': '819.28', 'spread': '3827.04', 'groupId': 'OG001'}, {'value': '142.17', 'spread': '703.24', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).', 'description': "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.\n\nFor 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.", 'unitOfMeasure': 'Euro (€)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10 to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%.'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%.'}], 'classes': [{'title': 'Total annual IPF-related costs', 'categories': [{'measurements': [{'value': '22261.30', 'spread': '14568.38', 'groupId': 'OG000'}, {'value': '20986.06', 'spread': '10864.08', 'groupId': 'OG001'}, {'value': '26171.47', 'spread': '17009.81', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct health IPF-related costs', 'categories': [{'measurements': [{'value': '21926.97', 'spread': '14418.41', 'groupId': 'OG000'}, {'value': '20939.38', 'spread': '10847.61', 'groupId': 'OG001'}, {'value': '25818.15', 'spread': '16606.63', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct non-health IPF-related costs', 'categories': [{'measurements': [{'value': '331.35', 'spread': '918.61', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '349.66', 'spread': '1511.20', 'groupId': 'OG002'}]}]}, {'title': 'Annual indirect IPF-related costs', 'categories': [{'measurements': [{'value': '2.99', 'spread': '14.63', 'groupId': 'OG000'}, {'value': '46.68', 'spread': '185.74', 'groupId': 'OG001'}, {'value': '3.65', 'spread': '24.86', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4711', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Total annual IPF-related costs'}, {'pValue': '0.4095', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual direct health IPF-related costs'}, {'pValue': '0.0435', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual direct non-health IPF-related costs'}, {'pValue': '0.5479', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual indirect IPF-related costs'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': '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%.\n\nFVC decline is calculated: FVC% (T12)- FVC%(T0)).\n\nIn order to estimate the direct and indirect costs according to FVC decline the following variable were described:\n\nFVC 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%', 'unitOfMeasure': 'Euro (€)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Overall FVC Patient Group.'}, {'type': 'SECONDARY', 'title': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with less than -10% FVC decline.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to - 5%.'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%.'}], 'classes': [{'title': 'Total annual IPF-related costs', 'categories': [{'measurements': [{'value': '48035.14', 'spread': '32937.16', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct health IPF-related costs', 'categories': [{'measurements': [{'value': '45646.56', 'spread': '32130.57', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct non-health related costs', 'categories': [{'measurements': [{'value': '2388.58', 'spread': '3902.02', 'groupId': 'OG002'}]}]}, {'title': 'Annual indirect IPF-related costs', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': '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%.\n\nFVC decline is calculated: FVC% (T12)- FVC%(T0)).\n\nIn order to estimate the direct and indirect costs according to FVC decline the following variable were described:\n\nFVC 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%\n\nResults are reported for participants with predicted FVC \\<50% at baseline.', 'unitOfMeasure': 'Euro (€)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup with predicted FVC \\<50% at T0.'}, {'type': 'SECONDARY', 'title': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with less than -10% FVC decline.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%.'}], 'classes': [{'title': 'Total annual IPF-related costs', 'categories': [{'measurements': [{'value': '24208.51', 'spread': '14372.38', 'groupId': 'OG000'}, {'value': '20546.19', 'spread': '11062.92', 'groupId': 'OG001'}, {'value': '23539.60', 'spread': '11999.95', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct health IPF-related costs', 'categories': [{'measurements': [{'value': '23826.41', 'spread': '14251.63', 'groupId': 'OG000'}, {'value': '20490.53', 'spread': '11041.18', 'groupId': 'OG001'}, {'value': '23450.00', 'spread': '12009.78', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct non-healt IPF-related costs', 'categories': [{'measurements': [{'value': '378.68', 'spread': '975.49', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '84.75', 'spread': '574.20', 'groupId': 'OG002'}]}]}, {'title': 'Annual indirect IPF-related costs', 'categories': [{'measurements': [{'value': '3.41', 'spread': '15.64', 'groupId': 'OG000'}, {'value': '55.66', 'spread': '202.19', 'groupId': 'OG001'}, {'value': '4.85', 'spread': '28.60', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7486', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Total annual IPF-related costs'}, {'pValue': '0.7652', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual direct health IPF-related costs'}, {'pValue': '0.0037', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual direct non-health IPF-related costs'}, {'pValue': '0.6119', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual indirect IPF-related costs'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': '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%.\n\nFVC decline is calculated: FVC% (T12)- FVC%(T0)).\n\nIn order to estimate the direct and indirect costs according to FVC decline the following variable were described:\n\nMen: 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%\n\nResults are reported for participants with predicted FVC 50-80% at baseline.', 'unitOfMeasure': 'Euro (€)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup predicted FVC 50-80% at T0.'}, {'type': 'SECONDARY', 'title': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%.'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%.'}], 'classes': [{'title': 'Total annual IPF-related costs', 'categories': [{'measurements': [{'value': '8630.88', 'spread': '7522.53', 'groupId': 'OG000'}, {'value': '23273.38', 'spread': '10606.04', 'groupId': 'OG001'}, {'value': '23810.32', 'spread': '12580.11', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct health IPF-related costs', 'categories': [{'measurements': [{'value': '8630.88', 'spread': '7522.53', 'groupId': 'OG000'}, {'value': '23273.38', 'spread': '10606.04', 'groupId': 'OG001'}, {'value': '23576.99', 'spread': '13010.66', 'groupId': 'OG002'}]}]}, {'title': 'Annual direct non-health IPF-related costs', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '233.33', 'spread': '808.29', 'groupId': 'OG002'}]}]}, {'title': 'Annual indirect IPF-related costs', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1581', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Total annual IPF-related costs'}, {'pValue': '0.1581', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual direct health IPF-related costs'}, {'pValue': '0.7165', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual direct non-health IPF-related costs'}, {'pValue': '1.0000', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Annual indirect IPF-related costs'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': '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%.\n\nFVC decline is calculated: FVC% (T12)- FVC%(T0)).\n\nIn order to estimate the direct and indirect costs according to FVC decline the following variable were described:\n\nMen: 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%\n\nResults are reported for participants with predicted FVC \\> 80% at baseline.', 'unitOfMeasure': 'Euro (€)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable Population (cost) including participants with FVC decline between T0 and T12 (paired data) - Subgroup with predicted FVC \\>80% at T0.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.49', 'spread': '17.16', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '11.71', 'groupId': 'OG001'}, {'value': '0.23', 'spread': '13.11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0733', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': 'Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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).\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the Quality of Life according to FVC decline the following variable were described:\n\nFVC % 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years).\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.93', 'spread': '29.03', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': 'Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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).\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate SGRQ according to FVC decline the following variable were described:\n\nMen: 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years).\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%\n\nResults are reported for participants with predicted FVC\\<50% at baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.58', 'spread': '14.02', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '12.16', 'groupId': 'OG001'}, {'value': '2.16', 'spread': '9.62', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0207', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months (At baseline visit (T0) and at 12 month visit (T12)).', 'description': 'Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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).\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nResults are reported for participants with predicted FVC 50-80% at baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.97', 'spread': '19.38', 'groupId': 'OG000'}, {'value': '8.43', 'spread': '8.32', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '6.93', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0942', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': 'Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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).\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nResults are reported for participants with predicted FVC \\>80% at baseline.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%.'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.96', 'spread': '17.74', 'groupId': 'OG000'}, {'value': '-6.16', 'spread': '18.69', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '14.79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0747', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': "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.\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the EQ-VAS according to FVC decline the following variable were described:\n\nFVC % predicted along the study:\n\nMen: 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%", 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%.'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%'}], 'classes': [{'categories': [{'measurements': [{'value': '13.89', 'spread': '13.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': "Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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.\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the EQ-VAS according to FVC decline the following variable were described:\n\nFVC % predicted along the study:\n\nMen: 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)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5% Results are reported for participants with predicted FVC\\<50% at baseline.", 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%.'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.48', 'spread': '18.21', 'groupId': 'OG000'}, {'value': '-6.96', 'spread': '20.15', 'groupId': 'OG001'}, {'value': '-1.45', 'spread': '14.77', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1282', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': "Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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.\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the EQ-VAS according to FVC decline the following variable were described:\n\nFVC % 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)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5% Results are reported for participants with predicted FVC 50-80% at baseline.", 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': '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', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '<-10% FVC Decline', 'description': 'IPF patients with FVC decline less than -10%.'}, {'id': 'OG001', 'title': 'From -10% to -5% FVC Decline', 'description': 'IPF patients with FVC decline from -10% to -5%.'}, {'id': 'OG002', 'title': '>-5% FVC Decline', 'description': 'IPF patients with FVC decline more than -5%'}], 'classes': [{'categories': [{'measurements': [{'value': '1.67', 'spread': '10.41', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '7.58', 'groupId': 'OG001'}, {'value': '-2.92', 'spread': '10.54', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7471', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': "Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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.\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the EQ-VAS according to FVC decline the following variable were described:\n\nFVC % 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)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5% Results are reported for participants with predicted FVC\\>80% at baseline.", 'unitOfMeasure': 'Score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers', 'description': 'Caregivers of patients with Idiopathic Pulmonary Fibrosis.'}], 'classes': [{'title': 'T0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.59', 'spread': '15.81', 'groupId': 'OG000'}]}]}, {'title': 'T6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.50', 'spread': '17.99', 'groupId': 'OG000'}]}]}, {'title': 'T12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.08', 'spread': '19.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).', 'description': '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).\n\nThe 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).', 'unitOfMeasure': 'Score an a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Caregivers who have signed the specific written informed consent.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Patients With IPF - Overall Population', 'description': 'All patients with Idiopathic Pulmonary Fibrosis (IPF).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'At inclusion visit (T0)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}]}, {'type': 'COMPLETED', 'comment': 'At 12 month visit (T12)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Lung transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}]}], 'recruitmentDetails': '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.', 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'IPF Patients With Predicted FVC <50% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value below 50% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'BG001', 'title': 'IPF Patients With Predicted FVC 50-80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value between 50 and 80% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'BG002', 'title': 'IPF Patients With Predicted FVC >80% at T0 - Subgroup', 'description': 'All patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) and predicted Forced Vital Capacity (FVC)% value above 80% at baseline visit (T0).\n\nPatient 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).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '70.32', 'spread': '8.52', 'groupId': 'BG000'}, {'value': '71.36', 'spread': '7.21', 'groupId': 'BG001'}, {'value': '68.33', 'spread': '8.54', 'groupId': 'BG002'}, {'value': '70.80', 'spread': '7.60', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': '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.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-30', 'size': 13540039, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-09-08T13:10', 'hasProtocol': False}, {'date': '2017-06-15', 'size': 506448, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-10-13T04:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-16', 'studyFirstSubmitDate': '2017-11-16', 'resultsFirstSubmitDate': '2020-09-10', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-10', 'studyFirstPostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs', 'timeFrame': '12 months. (At baseline visit (T0), at 6 months visit (T6) and at 12 month visit (T12)).', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through Saint George´s Respiratory Questionaire (SGRQ)', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).', 'description': '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.'}, {'measure': 'Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through EuroQoL Visual Analogue Scale (EQ-VAS)', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).', 'description': '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).\n\nThe number of participants analysed displays the number of participants with available data at the timepoint of interests.'}, {'measure': 'Quality of Life (QoL) of Patients With Idiopathic Pulmonary Fibrosis (IPF), Through Barthel Index', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).', 'description': 'The Quality of Life of patients with IPF according to Forced Vital Capacity (FVC)% predicted value is assessed through the Barthel Index.\n\nBarthel 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.\n\nThe number of participants analysed displays the number of participants with available data at the timepoint of interests.'}, {'measure': 'Number of Idiopathic Pulmonary Fibrosis (IPF)-Patients With Acute Exacerbations Along One Year', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6) and at 12 month visit (T12)).', 'description': 'Number of IPF-patients with acute exacerbations according to Forced Vital Capacity (FVC)% that occured along one year.\n\nAcute exacerbation is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new widespread alveolar abnormality.'}, {'measure': 'Total Annual Acute Exacerbation-related Costs', 'timeFrame': '12 months. (At baseline visit (T0), at 6 months visit (T6) at 12 month visit (T12)).', 'description': "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.\n\nFor 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."}, {'measure': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Overall FVC Patient Group', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': '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%.\n\nFVC decline is calculated: FVC% (T12)- FVC%(T0)).\n\nIn order to estimate the direct and indirect costs according to FVC decline the following variable were described:\n\nFVC 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%'}, {'measure': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC<50% at T0', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': '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%.\n\nFVC decline is calculated: FVC% (T12)- FVC%(T0)).\n\nIn order to estimate the direct and indirect costs according to FVC decline the following variable were described:\n\nFVC 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%\n\nResults are reported for participants with predicted FVC \\<50% at baseline.'}, {'measure': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC 50-80% at T0', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': '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%.\n\nFVC decline is calculated: FVC% (T12)- FVC%(T0)).\n\nIn order to estimate the direct and indirect costs according to FVC decline the following variable were described:\n\nMen: 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%\n\nResults are reported for participants with predicted FVC 50-80% at baseline.'}, {'measure': 'Idiopathic Pulmonary Fibrosis (IPF)-Related Costs by Forced Vital Capacity (FVC) Decline - Subgroup: Predicted FVC>80% at T0', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': '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%.\n\nFVC decline is calculated: FVC% (T12)- FVC%(T0)).\n\nIn order to estimate the direct and indirect costs according to FVC decline the following variable were described:\n\nMen: 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%\n\nResults are reported for participants with predicted FVC \\> 80% at baseline.'}, {'measure': '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', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': 'Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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).\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the Quality of Life according to FVC decline the following variable were described:\n\nFVC % 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years).\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%'}, {'measure': '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', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': 'Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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).\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate SGRQ according to FVC decline the following variable were described:\n\nMen: 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years).\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%\n\nResults are reported for participants with predicted FVC\\<50% at baseline.'}, {'measure': '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', 'timeFrame': '12 months (At baseline visit (T0) and at 12 month visit (T12)).', 'description': 'Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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).\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nResults are reported for participants with predicted FVC 50-80% at baseline.'}, {'measure': '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', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': 'Absolute Change in SGRQ score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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).\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nResults are reported for participants with predicted FVC \\>80% at baseline.'}, {'measure': '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', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': "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.\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the EQ-VAS according to FVC decline the following variable were described:\n\nFVC % predicted along the study:\n\nMen: 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)\n\n(FVC is FVC in liters, T is height in cm and E is age in years)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5%"}, {'measure': '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', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': "Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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.\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the EQ-VAS according to FVC decline the following variable were described:\n\nFVC % predicted along the study:\n\nMen: 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)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5% Results are reported for participants with predicted FVC\\<50% at baseline."}, {'measure': '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', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': "Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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.\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the EQ-VAS according to FVC decline the following variable were described:\n\nFVC % 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)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5% Results are reported for participants with predicted FVC 50-80% at baseline."}, {'measure': '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', 'timeFrame': '12 months. (At baseline visit (T0) and at 12 month visit (T12)).', 'description': "Absolute Change in EQ-VAS score by FVC decline according to predicted FVC% from baseline visit (T0) to 12 month visit (T12).\n\nThe 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.\n\nFVC decline: FVC% (T12)- FVC%(T0)\n\nIn order to estimate the EQ-VAS according to FVC decline the following variable were described:\n\nFVC % 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)\n\nThe calculated variable was stratified into the following subgroups between T0 and T12:\n\n≤-10%; from -10% to -5%; \\>-5% Results are reported for participants with predicted FVC\\>80% at baseline."}, {'measure': 'Impact of Disease on the Patients Caregiver Through Zarit Burden Interview Questionaire', 'timeFrame': '12 months. (At baseline visit (T0), at 6 month visit (T6), at 12 month visit (T12)).', 'description': '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).\n\nThe 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).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': '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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and male patients ≥ 40 years of age\n* Patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) according to last ATS/ERS/JRS/ALAT IPF guideline for diagnosis and management consensus\n* Written informed consent prior to participation\n\nExclusion Criteria:\n\n* Inability for the patient to understand or complete the written Inform Consent or patients questionnaires or to understand Spanish\n* Current participation in any clinical trial\n* Patients for whom further follow-up is not possible at the enrolling site'}, 'identificationModule': {'nctId': 'NCT03386994', 'briefTitle': 'OASIS-IPF (Idiopathic Pulmonary Fibrosis) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Observational Analysis on the Socio-economic Impact of IPF in Spain', 'orgStudyIdInfo': {'id': '1199-0296'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Idiopathic Pulmonary Fibrosis patients', 'description': 'all IPF patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03010', 'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'zip': '06080', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Hospital Infanta Cristina', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}, {'zip': '48903', 'city': 'Barakaldo (Vizcaya)', 'country': 'Spain', 'facility': 'Hospital Universitario Cruces', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '8003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'H. del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "H. U. Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'H. U. de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8916', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'H. U. Germans Trias i Pujol', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '09006', 'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario de Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '30202', 'city': 'Cartagena (Murcia)', 'country': 'Spain', 'facility': 'Hospital General Universitario Santa Lucía', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'zip': '12004', 'city': 'Castellon', 'country': 'Spain', 'facility': 'Hospital General Universitario de Castellón', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'H. U. de Girona Doctor Josep Trueta', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '7800', 'city': 'Ibiza Town', 'country': 'Spain', 'facility': 'Can Misses', 'geoPoint': {'lat': 38.90883, 'lon': 1.43296}}, {'zip': '27003', 'city': 'Lugo', 'country': 'Spain', 'facility': 'Hospital Universitario Lucus Augusti', 'geoPoint': {'lat': 43.00992, 'lon': -7.55602}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'H. Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Majadahonda (Madrid)', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'zip': '7198', 'city': 'Mallorca', 'country': 'Spain', 'facility': 'H. Son Llatzer'}, {'zip': '7500', 'city': 'Mallorca', 'country': 'Spain', 'facility': 'H. de Manacor'}, {'zip': '29603', 'city': 'Marbella (Málaga)', 'country': 'Spain', 'facility': 'Hospital Costa del Sol', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Universitario de Málaga', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '7703', 'city': 'Menorca', 'country': 'Spain', 'facility': 'H. Mateu Orfila'}, {'zip': '36071', 'city': 'Mourente (Pontevedra)', 'country': 'Spain', 'facility': 'Hospital Montecelo', 'geoPoint': {'lat': 42.43333, 'lon': -8.61667}}, {'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'facility': 'CHU de Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '33011', 'city': 'Oviedo', 'country': 'Spain', 'facility': 'H. Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '07020', 'city': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Universitari Son Espases', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'zip': '20014', 'city': 'San Sebastián', 'country': 'Spain', 'facility': 'Hospital Universitario Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Santiago', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '39300', 'city': 'Torrelavega (Cantabria)', 'country': 'Spain', 'facility': 'Hospital Sierrallana y Tres Mares', 'geoPoint': {'lat': 43.34943, 'lon': -4.04785}}, {'zip': '47003', 'city': 'Valladolid', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Mireia Canals, +34607550925', 'role': 'STUDY_CHAIR', 'affiliation': 'mireia.canals@boehringer-ingelheim.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}