Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-01-01 @ 7:27 AM
Study NCT ID:
NCT03242759
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2017-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}, {'id': 'C093844', 'term': 'pirfenidone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.\n\nInvestigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.\n\nBI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline until end of follow-up, up to 899 days.', 'description': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.', 'eventGroups': [{'id': 'EG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 36, 'seriousNumAtRisk': 88, 'deathsNumAffected': 28, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 2, 'seriousNumAtRisk': 13, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alanine aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aspartate aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'seriousEvents': [{'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Alanine aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aspartate aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Intraventricular haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Idiopathic pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 13, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '10.78', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '7.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.505', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.181', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.', 'unitOfMeasure': 'Percentage of predicted FVC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '7.74', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '4.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.571', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.232', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.', 'unitOfMeasure': 'Percentage of predicted FVC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.3', 'spread': '10.47', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '8.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.375', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported', 'unitOfMeasure': 'Percentage of predicted DLco', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '6.83', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '6.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.938', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.', 'unitOfMeasure': 'Percentage of predicted DLco', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all 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baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.', 'unitOfMeasure': 'Percentage of predicted SpO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '0.84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.018', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.125', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.', 'unitOfMeasure': 'Percentage of predicted SpO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary 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['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.', 'unitOfMeasure': 'Percentage of predicted TLC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.3', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '6.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.281', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.', 'unitOfMeasure': 'Percentage of predicted TLC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.8', 'spread': '10.18', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '1.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.008', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.', 'unitOfMeasure': 'Percentage of predicted IC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'PRIMARY', 'title': 'Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.5', 'spread': '5.00', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '2.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.031', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.', 'unitOfMeasure': 'Percentage of predicted IC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '497.0', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '751.0'}, {'value': '521.5', 'groupId': 'OG001', 'lowerLimit': '111.0', 'upperLimit': '721.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until end of follow-up, up to 899 days.', 'description': 'Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '16.52', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '8.12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.939', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 52.', 'description': 'The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '13.36', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '6.17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.169', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.545', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 100.', 'description': 'The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '7.80', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.333', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.786', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 52', 'description': "The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '4.37', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '2.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.245', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.454', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 100', 'description': "The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Annual Change in Six-Minute Walk Test (6MWT) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.6', 'spread': '60.42', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '31.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.543', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.733', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.', 'unitOfMeasure': 'Meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Annual Change in Six-Minute Walk Test (6MWT) at Week 100', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.7', 'spread': '36.60', 'groupId': 'OG000'}, {'value': '-2.3', 'spread': '20.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.046', 'groupIds': ['OG000'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.898', 'groupIds': ['OG001'], 'groupDescription': 'Intra-group difference comparing to baseline was analyzed.', 'statisticalMethod': 'Paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.', 'unitOfMeasure': 'Meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'categories': [{'measurements': [{'value': '686.0', 'groupId': 'OG000', 'lowerLimit': '14.0', 'upperLimit': '899.0'}, {'value': '641.0', 'groupId': 'OG001', 'lowerLimit': '111.0', 'upperLimit': '721.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline until end of follow-up, up to 899 days.', 'description': 'Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Death Reason Categories', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'OG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'classes': [{'title': 'Related to idiopathic pulmonary fibrosis', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Related to comorbidity', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline until end of follow-up, up to 899 days.', 'description': 'Number of participants per death reason categories was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible patients who died during the study. All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'FG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Administrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Change visit schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This was a non-interventional multi-center study based on newly collected data on idiopathic pulmonary fibrosis (IPF) patients in clinical practice in Taiwan with a planned 2-year followed-up period to characterize the IPF population in Taiwan with regard to their clinical course under clinical practice conditions in Taiwan.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.\n\nSubjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and used anti-fibrotic drug were included in this group.'}, {'id': 'BG001', 'title': 'Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug', 'description': 'Eligible patients with idiopathic pulmonary fibrosis (IPF) who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria, recruiting from 10 hospitals in Taiwan, and did not use anti-fibrotic drug were included in this group.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '74.7', 'spread': '8.97', 'groupId': 'BG000'}, {'value': '74.1', 'spread': '10.64', 'groupId': 'BG001'}, {'value': '74.6', 'spread': '9.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Oriental', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Percent predicted Forced Vital Capacity (FVC) of lung function', 'classes': [{'categories': [{'measurements': [{'value': '69.7', 'spread': '14.06', 'groupId': 'BG000'}, {'value': '97.8', 'spread': '10.97', 'groupId': 'BG001'}, {'value': '73.3', 'spread': '16.64', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures of percentages of predicted Forced Vital Capacity of lung function (FVC) were shown.', 'unitOfMeasure': 'Percentage of predicted FVC', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) of lung function', 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'spread': '19.74', 'groupId': 'BG000'}, {'value': '57.5', 'spread': '17.96', 'groupId': 'BG001'}, {'value': '45.2', 'spread': '20.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures of the percentages of predicted diffusing capacity of the Lungs for Carbon monoxide (DLco) were shown.', 'unitOfMeasure': 'Percentage of perdicted DLco', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent predicted oxygen saturation (SpO2)', 'classes': [{'categories': [{'measurements': [{'value': '95.5', 'spread': '2.31', 'groupId': 'BG000'}, {'value': '97.5', 'spread': '1.69', 'groupId': 'BG001'}, {'value': '95.8', 'spread': '2.33', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures of percentages of predicted oxygen saturation (SpO2) were shown.', 'unitOfMeasure': 'Percentage of predicted SpO2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent predicted Total Lung Capacity (TLC)', 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'spread': '13.25', 'groupId': 'BG000'}, {'value': '100.2', 'spread': '13.04', 'groupId': 'BG001'}, {'value': '77.2', 'spread': '15.50', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures of the percentages of predicted Total Lung Capacity (TLC) were shown.', 'unitOfMeasure': 'Percentage of perdicted TLC', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Percent predicted Inspiratory Capacity (IC)', 'classes': [{'categories': [{'measurements': [{'value': '62.8', 'spread': '15.62', 'groupId': 'BG000'}, {'value': '87.5', 'spread': '21.49', 'groupId': 'BG001'}, {'value': '65.6', 'spread': '17.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline measures of the percentages of predicted Inspiratory Capacity (IC) were shown.', 'unitOfMeasure': 'Percentage of perdicted IC', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-10', 'size': 324421, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-11T08:32', 'hasProtocol': True}, {'date': '2020-04-21', 'size': 249332, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-11T08:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-19', 'studyFirstSubmitDate': '2017-08-03', 'resultsFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2017-08-07', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-15', 'studyFirstPostDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.'}, {'measure': 'Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.'}], 'secondaryOutcomes': [{'measure': 'Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis', 'timeFrame': 'From baseline until end of follow-up, up to 899 days.', 'description': 'Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported.'}, {'measure': 'Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52', 'timeFrame': 'At baseline and Week 52.', 'description': 'The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 was reported.'}, {'measure': 'Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100', 'timeFrame': 'At baseline and Week 100.', 'description': 'The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. The questionnaire included 3 subscales measures: symptoms, activity limitation, and social, and emotional impact of disease (each subscale score ranges from 0 to 100 with higher score indicating poorer quality of life). The SGRQ total score was calculated by summing weights from all positive items, divided by sum of weights for all items in SGRQ questionnaire and multiplying by 100. The total score of SGRQ ranged from 0 (no effect on quality of life) to 100 (maximum perceived distress). Thus, a higher score indicated a poorer quality of life. Annual change in score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 was reported.'}, {'measure': 'Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52', 'timeFrame': 'At baseline and Week 52', 'description': "The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status."}, {'measure': 'Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100', 'timeFrame': 'At baseline and Week 100', 'description': "The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is an 8-item, health status instrument which provides a method for assessing the impact of COPD on the patient's health and quality of life. The CAT score (ranging from 0 to 40) was calculated for each individual by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status."}, {'measure': 'Annual Change in Six-Minute Walk Test (6MWT) at Week 52', 'timeFrame': 'At baseline and Week 52.', 'description': 'Annual change in Six-Minute Walk Test (6MWT) at Week 52 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.'}, {'measure': 'Annual Change in Six-Minute Walk Test (6MWT) at Week 100', 'timeFrame': 'At baseline and Week 100.', 'description': 'Annual change in Six-Minute Walk Test (6MWT) at Week 100 was reported. The 6MWT measured the distance that a person can walk in 6 minutes, providing information regarding functional capacity, response to therapy and prognosis.'}, {'measure': 'Overall Survival', 'timeFrame': 'From baseline until end of follow-up, up to 899 days.', 'description': 'Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause.'}, {'measure': 'Number of Participants Per Death Reason Categories', 'timeFrame': 'From baseline until end of follow-up, up to 899 days.', 'description': 'Number of participants per death reason categories was reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Fibrosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a non-interventional, multi-center study to collect data from patients with idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried out at 10 medical centers, the expert centers where IPF patients are mainly managed in Taiwan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be carried out at 10 medical centers, the expert centers where idiopathic pulmonary fibrosis (IPF) patients are mainly managed in Taiwan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients can be included if ALL the following criteria are met:\n\n 1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).\n* Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).\n* Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available. 2.Patient ≥ 20 years of age 3.Written informed consent prior to participation 4.Patients with further follow-up possible with participating physician during planned study period 5.Ability to read and write in the local language\n\nExclusion Criteria:\n\n* Patients should not be included if ANY of the following criteria is met:\n\n 1. Lung transplantation expected within next 6 months.\n 2. Inclusion in ongoing clinical trials.'}, 'identificationModule': {'nctId': 'NCT03242759', 'briefTitle': 'Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan', 'orgStudyIdInfo': {'id': '1199-0303'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with idiopathic pulmonary fibrosis (IPF)', 'interventionNames': ['Drug: nintedanib', 'Drug: pirfenidone']}], 'interventions': [{'name': 'nintedanib', 'type': 'DRUG', 'otherNames': ['OVEF'], 'description': 'Drug', 'armGroupLabels': ['patients with idiopathic pulmonary fibrosis (IPF)']}, {'name': 'pirfenidone', 'type': 'DRUG', 'description': 'Drug', 'armGroupLabels': ['patients with idiopathic pulmonary fibrosis (IPF)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '500', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Chang-Hua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '83301', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Chang Gung Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '220', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '404', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '40705', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '10048', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '114', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '333', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital(Linkou)', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}