Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with idiopathic pulmonary fibrosis (IPF) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nintedanib | Drug | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52 | Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported. | At baseline and Week 52. |
| Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100 | Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported. | At baseline and Week 100. |
| Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52 | Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported | At baseline and Week 52. |
| Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100 | Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported. | At baseline and Week 100. |
| Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52 | Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported. | At baseline and Week 52. |
| Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100 | Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis | Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported. | From baseline until end of follow-up, up to 899 days. |
| Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 |
Not provided
Inclusion Criteria:
Patients can be included if ALL the following criteria are met:
1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).
Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).
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
Exclusion Criteria:
Patients should not be included if ANY of the following criteria is met:
Not provided
Not provided
Not provided
The study will be carried out at 10 medical centers, the expert centers where idiopathic pulmonary fibrosis (IPF) patients are mainly managed in Taiwan.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang-Hua Christian Hospital | Changhua | 500 | Taiwan | |||
| Kaohsiung Medical University Chung-Ho Memorial Hospital |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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. |
| FG001 | Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52 | Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted FVC | At baseline and Week 52. |
|
From baseline until end of follow-up, up to 899 days.
All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Idiopathic Pulmonary Fibrosis With Anti-fibrotic Drug | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 23.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 10, 2017 | Feb 11, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2020 | Feb 11, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C530716 | nintedanib |
| C093844 | pirfenidone |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| pirfenidone | Drug | Drug |
|
| At baseline and Week 100. |
| Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52 | Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported. | At baseline and Week 52. |
| Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100 | Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported. | At baseline and Week 100. |
| Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52 | Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported. | At baseline and Week 52. |
| Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100 | Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported. | At baseline and Week 100. |
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. |
| At baseline and Week 52. |
| Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 | 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. | At baseline and Week 100. |
| Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52 | 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. | At baseline and Week 52 |
| Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100 | 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. | At baseline and Week 100 |
| Annual Change in Six-Minute Walk Test (6MWT) at Week 52 | 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. | At baseline and Week 52. |
| Annual Change in Six-Minute Walk Test (6MWT) at Week 100 | 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. | At baseline and Week 100. |
| Overall Survival | Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause. | From baseline until end of follow-up, up to 899 days. |
| Number of Participants Per Death Reason Categories | Number of participants per death reason categories was reported. | From baseline until end of follow-up, up to 899 days. |
| Kaohsiung City |
| 807 |
| Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 83301 | Taiwan |
| Far Eastern Memorial Hospital | New Taipei City | 220 | Taiwan |
| China Medical University Hospital | Taichung | 404 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 40705 | Taiwan |
| National Taiwan University Hospital | Taipei | 10048 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| Chang Gung Memorial Hospital(Linkou) | Taoyuan | 333 | Taiwan |
| Lost to Follow-up |
|
| Administrative problems |
|
| Death |
|
| Change visit schedule |
|
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug |
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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Percent predicted Forced Vital Capacity (FVC) of lung function | Baseline measures of percentages of predicted Forced Vital Capacity of lung function (FVC) were shown. | Mean | Standard Deviation | Percentage of predicted FVC |
|
| Percent predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) of lung function | Baseline measures of the percentages of predicted diffusing capacity of the Lungs for Carbon monoxide (DLco) were shown. | Mean | Standard Deviation | Percentage of perdicted DLco |
|
| Percent predicted oxygen saturation (SpO2) | Baseline measures of percentages of predicted oxygen saturation (SpO2) were shown. | Mean | Standard Deviation | Percentage of predicted SpO2 |
|
| Percent predicted Total Lung Capacity (TLC) | Baseline measures of the percentages of predicted Total Lung Capacity (TLC) were shown. | Mean | Standard Deviation | Percentage of perdicted TLC |
|
| Percent predicted Inspiratory Capacity (IC) | Baseline measures of the percentages of predicted Inspiratory Capacity (IC) were shown. | Mean | Standard Deviation | Percentage of perdicted IC |
|
| Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug |
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. |
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100 | Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted FVC | At baseline and Week 100. |
|
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52 | Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted DLco | At baseline and Week 52. |
|
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100 | Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted DLco | At baseline and Week 100. |
|
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52 | Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted SpO2 | At baseline and Week 52. |
|
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100 | Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted SpO2 | At baseline and Week 100. |
|
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52 | Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted TLC | At baseline and Week 52. |
|
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100 | Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted TLC | At baseline and Week 100. |
|
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52 | Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted IC | At baseline and Week 52. |
|
|
|
|
| Primary | Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100 | Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Percentage of predicted IC | At baseline and Week 100. |
|
|
|
|
| Secondary | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis | Time to first acute exacerbation of idiopathic pulmonary fibrosis was reported. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Median | Full Range | Days | From baseline until end of follow-up, up to 899 days. |
|
|
|
| Secondary | Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52 | 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. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and Week 52. |
|
|
|
|
| Secondary | Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100 | 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. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and Week 100. |
|
|
|
|
| Secondary | Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52 | 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. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and Week 52 |
|
|
|
|
| Secondary | Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100 | 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. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Score on a scale | At baseline and Week 100 |
|
|
|
|
| Secondary | Annual Change in Six-Minute Walk Test (6MWT) at Week 52 | 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. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Meter | At baseline and Week 52. |
|
|
|
|
| Secondary | Annual Change in Six-Minute Walk Test (6MWT) at Week 100 | 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. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Mean | Standard Deviation | Meter | At baseline and Week 100. |
|
|
|
|
| Secondary | Overall Survival | Overall survival was reported. Overall survival was defined as the time from randomization to death due to any cause. | All eligible patients: all patients who signed the informed consent and fulfilled all inclusion criteria and no exclusion criteria. | Posted | Median | Full Range | Days | From baseline until end of follow-up, up to 899 days. |
|
|
|
| Secondary | Number of Participants Per Death Reason Categories | Number of participants per death reason categories was reported. | 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. | Posted | Count of Participants | Participants | From baseline until end of follow-up, up to 899 days. |
|
|
|
| 28 |
| 88 |
| 29 |
| 88 |
| 36 |
| 88 |
| EG001 | Idiopathic Pulmonary Fibrosis Without Anti-fibrotic Drug | 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. | 1 | 13 | 2 | 13 | 2 | 13 |
| Acute myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 23.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
|
| Alanine aminotransferase abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Aspartate aminotransferase abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Alanine aminotransferase abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Aspartate aminotransferase abnormal | Investigations | MedDRA 23.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results.
Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days.
BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 0.232 |
| Other |
| 0.375 |
| Other |
| 0.938 |
| Other |
| 0.048 |
| Other |
| 0.125 |
| Other |
| 0.755 |
| Other |
| 0.281 |
| Other |
| 0.008 |
| Other |
| 0.031 |
| Other |
| 0.939 |
| Other |
| 0.545 |
| Other |
| 0.786 |
| Other |
| 0.454 |
| Other |
| 0.733 |
| Other |
| 0.898 |
| Other |
| Other |
|
| Unknown |
|