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To gain further insight on the characteristics, management, disease progression and the outcomes of patients with IPF, as diagnosed and treated under real-world, clinical practice conditions in Greece. More specifically, this registry will be used to: Provide a comprehensive clinical picture of IPF, Track access to health care and cost of caring for IPF patients over time, Examine the implementation of treatment guidelines used on patients diagnosed with IPF, according to the existing diagnosis guidelines, Characterization of patients on different treatments. To provide information regarding survival and mortality causes, IPF exacerbations as well as IPF patient co-morbidities including myocardial infarction, CNS infarction, other arterial thromboembolic events, deep vein thrombosis, hemorrhage, gastrointestinal perforation and pulmonary hypertension. Data regarding IPF patient hospitalization will be collected and evaluated with regards to potential respiratory causes, and there will be documentation of treatment patterns and economic aspects. Patients will be followed up for 2 years and information regarding IPF treatment changes since the last visit will be collected.
Purpose: To gain further knowledge on the characteristics, management, progression and outcomes of patients with IPF as treated under real-world, clinical practice conditions in Greece
Study Design:
National, multi-center, observational disease registry based on new data from a significant sample size of IPF patients in Greece. Patients will be followed up for 2 years and information will be collected during this time period. This is a non-interventional study and primary data collected during study visits will be used
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idiopathic Pulmonary Fibrosis (IPF) patients with less than 6 months diagnosis | |||
| Idiopathic Pulmonary Fibrosis (IPF) patients with equal or more than 6 months diagnosis |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit | Number in each category of non-pharmacological treatment (e.g. start of Long-term oxygen therapy (LTOT), new listing for lung transplantation, physiotherapy) for Idiopathic Pulmonary Fibrosis (IPF) by study visit is reported. The categories of non-pharmacological treatment for Idiopathic Pulmonary Fibrosis (IPF) are the following:
| At baseline visit and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
| Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit | Number of patients in each category of physician's clinical assessment of the probable course of IPF by study visit is reported. Physician's clinical rating of the probable course of IPF (stable, slow or rapid progression) was based on available Forced vital capacity (FVC) results, diffusion capacity for carbon monoxide (DLCO) results, physical examination, hospitalizations/events between the visits. The categories of physician's clinical assessment are the following:
| At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
| Number of Physician Contacts Per Patient by Study Visit | Number of physician contacts per patient is reported. For the baseline visit mean and standard deviation of physician contacts with the patient up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of physician contacts with the patient since the last study visit is reported. | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
| Number of Visits in Outpatient Department by Study Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients in Each Category of Concomitant Medications | Concomitant medication was defined as any treatment presented following the Informed Consent Form (ICF) signature. If stop date was missing in the electronic Case Report Form (eCRF), medication was considered as concomitant. The number of patients in each category of the following concomitant medications is reported. The concomitant medications are:
The categories for each concomitant medication listed above are the following:
|
Not provided
Inclusion criteria:
Newly diagnosed (less than 6 months) or patients previously diagnosed with IPF (more than 6 months from baseline visit), based upon the consensus statement jointly issued by ATS/ERS/JRS/ALAT in 2011 (see Annexes 6 and 7 for HRCT and histological criteria in Annex 6)
Age =40 years old at the time of inclusion
Written informed consent for participation in the registry
Patients that can be followed up further, during the scheduled study period
Exclusion criteria:
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Eligible for participation in the study patients must fulfill ALL the inclusion criteria and NONE of the exclusion criteria that are listed below and must be consecutively enrolled:
Newly diagnosed (less than 6 months) or patients previously diagnosed with IPF (more than 6 months from baseline visit), based upon the consensus statement jointly issued by ATS/ERS/JRS/ALAT in 2011
Age ≥40 years old at the time of inclusion
Written informed consent for participation in the registry
Patients that can be followed up further, during the scheduled study period
None of the following Exclusion Criteria should be fulfilled:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gen. Hosp. of Chest Diseases "Sotiria", Univ. Resp. Med. | Athens | 11527 | Greece | |||
| Sotiria Hospital Athens, 7th Pulmonary Clinic |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data- 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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 national, multi -center, observational disease and outcomes registry study based on new data from a significant sample size of Greek idiopathic pulmonary fibrosis (IPF) patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | IPF Patients With Less Than 6 Months Diagnosis | Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit. |
| FG001 | IPF Patients With Equal or More Than 6 Months Diagnosis | Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS) comprised of all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IPF Patients With Less Than 6 Months Diagnosis | Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit. |
| BG001 | IPF Patients With Equal or More Than 6 Months Diagnosis |
| 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 | Number of Patients in Each Category of Non-pharmacological Treatment for Idiopathic Pulmonary Fibrosis (IPF) by Study Visit | Number in each category of non-pharmacological treatment (e.g. start of Long-term oxygen therapy (LTOT), new listing for lung transplantation, physiotherapy) for Idiopathic Pulmonary Fibrosis (IPF) by study visit is reported. The categories of non-pharmacological treatment for Idiopathic Pulmonary Fibrosis (IPF) are the following:
| Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. | Posted | Count of Participants | Participants | At baseline visit and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
|
From signing the informed consent onwards until the end of the study, up to 24 months.
Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study.
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 | IPF Patients With Less Than 6 Months Diagnosis | Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | 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 | Feb 22, 2018 | Mar 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 13, 2020 | Mar 28, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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Number of visits in outpatient department by study visit is reported. For the baseline visit mean and standard deviation of visits in outpatient department up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in outpatient department since the last study visit is reported. |
| At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
| Number of Visits in Pulmonologists by Study Visit | Number of visits in pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in pulmonologists since the last study visit is reported. | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
| Number of Visits in Other Physicians Than the Pulmonologists by Study Visit | Number of visits in other physicians than the pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in other physicians than the pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in other physicians than the pulmonologists since the last study visit is reported. | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
| Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit | Number of Idiopathic Pulmonary Fibrosis (IPF) related procedures by study visit is reported. For the baseline visit mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures since the last study visit is reported. | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
| Number of Patients in Each Category of Hospitalizations by Study Visit | Number of patients in each category of hospitalizations by study visit is reported. For the baseline visit number of patients in each category of hospitalizations up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months number of patients in each category of hospitalizations since the last study visit is reported. The categories of hospitalization were:
| At baseline up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
| Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib | Number of patients in each category with usage of pirfenidone and nintedanib is reported. The categories for usage of pirfenidone and nintedanib are the following:
| From signing the informed consent onwards until the end of the study, up to 24 months. |
| From signing the informed consent onwards until the end of the study, up to 24 months. |
| Athens |
| 11527 |
| Greece |
| University General Hospital Attikon | Athens | 124 62 | Greece |
| University Hospital of Heraklion, University Pulmonology Cl | Heraklion | 71100 | Greece |
| General University Hospital of Larissa | Larissa | 41110 | Greece |
| A Pulmonology Clinic "G.Papanikolaou" Hospital Thessaloniki | Thessaloniki | 57010 | Greece |
| General Hospital of Thessaloniki "G. Papanikolaou" | Thessaloniki | 57010 | Greece |
Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Patients in Greece diagnosed less than 6 months (newly diagnosed) with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit.
| OG001 | IPF Patients With Equal or More Than 6 Months Diagnosis | Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit. |
|
|
| Primary | Number of Patients in Each Category of Physician's Clinical Assessment of the Probable Course of Idiopathic Pulmonary Fibrosis (IPF) by Study Visit | Number of patients in each category of physician's clinical assessment of the probable course of IPF by study visit is reported. Physician's clinical rating of the probable course of IPF (stable, slow or rapid progression) was based on available Forced vital capacity (FVC) results, diffusion capacity for carbon monoxide (DLCO) results, physical examination, hospitalizations/events between the visits. The categories of physician's clinical assessment are the following:
| Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported. | Posted | Count of Participants | Participants | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
|
|
|
| Primary | Number of Physician Contacts Per Patient by Study Visit | Number of physician contacts per patient is reported. For the baseline visit mean and standard deviation of physician contacts with the patient up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of physician contacts with the patient since the last study visit is reported. | Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported. | Posted | Mean | Standard Deviation | physician contacts per patient | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
|
|
|
| Primary | Number of Visits in Outpatient Department by Study Visit | Number of visits in outpatient department by study visit is reported. For the baseline visit mean and standard deviation of visits in outpatient department up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in outpatient department since the last study visit is reported. | Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported. | Posted | Mean | Standard Deviation | visits per patient | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
|
|
|
| Primary | Number of Visits in Pulmonologists by Study Visit | Number of visits in pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in pulmonologists since the last study visit is reported. | Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported. | Posted | Mean | Standard Deviation | visits per patient | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
|
|
|
| Primary | Number of Visits in Other Physicians Than the Pulmonologists by Study Visit | Number of visits in other physicians than the pulmonologists by study visit is reported. For the baseline visit mean and standard deviation of visits in other physicians than the pulmonologists up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of visits in other physicians than the pulmonologists since the last study visit is reported. | Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported. | Posted | Mean | Standard Deviation | visits per patient | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
|
|
|
| Primary | Number of Idiopathic Pulmonary Fibrosis (IPF) Related Procedures by Study Visit | Number of Idiopathic Pulmonary Fibrosis (IPF) related procedures by study visit is reported. For the baseline visit mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months mean and standard deviation of Idiopathic Pulmonary Fibrosis (IPF) related procedures since the last study visit is reported. | Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. Only participants with non-missing results are reported. | Posted | Mean | Standard Deviation | IPF related procedures per patient | At baseline (up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
|
|
|
| Primary | Number of Patients in Each Category of Hospitalizations by Study Visit | Number of patients in each category of hospitalizations by study visit is reported. For the baseline visit number of patients in each category of hospitalizations up to 12 months prior to baseline visit is reported. For the study visits at 3 months, at 6 months, at 12 months, at 18 months and at 24 months number of patients in each category of hospitalizations since the last study visit is reported. The categories of hospitalization were:
| Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. | Posted | Count of Participants | Participants | At baseline up to 12 months prior to baseline visit) and at 3 months, at 6 months, at 12 months, at 18 months and at 24 months after the baseline visit. |
|
|
|
| Primary | Number of Patients in Each Category With Usage of Pirfenidone and Nintedanib | Number of patients in each category with usage of pirfenidone and nintedanib is reported. The categories for usage of pirfenidone and nintedanib are the following:
| Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. | Posted | Count of Participants | Participants | From signing the informed consent onwards until the end of the study, up to 24 months. |
|
|
|
| Secondary | Number of Patients in Each Category of Concomitant Medications | Concomitant medication was defined as any treatment presented following the Informed Consent Form (ICF) signature. If stop date was missing in the electronic Case Report Form (eCRF), medication was considered as concomitant. The number of patients in each category of the following concomitant medications is reported. The concomitant medications are:
The categories for each concomitant medication listed above are the following:
| Full Analysis Set (FAS) comprised all subjects enrolled in the study with at least one measurement of any of the primary endpoints during the study. This population was used to run any statistics of the study. | Posted | Count of Participants | Participants | From signing the informed consent onwards until the end of the study, up to 24 months. |
|
|
|
| 10 |
| 96 |
| 7 |
| 96 |
| 10 |
| 96 |
| EG001 | IPF Patients With Equal or More Than 6 Months Diagnosis | Patients in Greece diagnosed since 6 or more months with Idiopathic Pulmonary Fibrosis (IPF) from the study baseline visit. | 45 | 205 | 22 | 205 | 21 | 205 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Cardiopulmonary failure | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 24.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
|
| Transplantation complication | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 24.1 | Systematic Assessment |
|
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
|
| Ischaemic stroke | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | 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.
| Unknown |
|
| Missing |
|
| Unknown |
|
| Missing |
|
| Unknown |
|
| Missing |
|
| Unknown |
|
| Missing |
|
| Unknown |
|
| Missing |
|
| Rapid progression |
|
| No judgement possible |
|
| Missing |
|
| 3 months (since last visit) |
|
| 6 months (since last visit) |
|
| 12 months (since last visit) |
|
| 18 months (since last visit) |
|
| 24 months (since last visit) |
|
|
| 6 months (since last visit) |
|
|
| 12 months (since last visit) |
|
|
| 18 months (since last visit) |
|
|
| 24 months (since last visit) |
|
|
|
| 6 months (since last visit) |
|
|
| 12 months (since last visit) |
|
|
| 18 months (since last visit) |
|
|
| 24 months (since last visit) |
|
|
|
| 6 months (since last visit) |
|
|
| 12 months (since last visit) |
|
|
| 18 months (since last visit) |
|
|
| 24 months (since last visit) |
|
|
|
| 6 months (since last visit) |
|
|
| 12 months (since last visit) |
|
|
| 18 months (since last visit) |
|
|
| 24 months (since last visit) |
|
|
|
| 6 months (since last visit) |
|
|
| 12 months (since last visit) |
|
|
| 18 months (since last visit) |
|
|
| 24 months (since last visit) |
|
|
| Unknown |
|
| Missing |
|
| 3 months (since last visit) |
|
| 6 months (since last visit) |
|
| 12 months (since last visit) |
|
| 18 months (since last visit) |
|
| 24 months (since last visit) |
|
| Unknown |
|
| Missing |
|
| Nintedanib |
|
| Unknown |
|
| Missing |
|
| N-Acetylcysteine |
|
| Azathioprine |
|
| Cyclophosphamide |
|
| Cyclosporine A |
|
| Other immuno-suppressant |
|
| Anticoagulants |
|
| GERD medication |
|
| PDE-5 inhibitor |
|
| Endothelin receptor antagonist |
|
| NSAIDs other than aspirin |
|
| Hormonal contraceptives |
|
| Hormone replacement therapy |
|
| Anti-VEGF drugs |
|
| Other |
|