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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS36605 | Registry Identifier | HMA-EMA Catalogues of real-world data sources and studies |
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The primary objective is to evaluate the incidence of adverse drug reactions (focus on hepatic function disorders) of Ofev Capsules under the real world setting in patients with Chronic fibrosing Interstitial Lung Diseases with a progressive phenotype (PF-ILD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ofev Capsules | Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Ofev Capsules as prescribed by the treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Drug Reactions (ADRs) | Incidence of adverse drug reactions (ADRs) is reported as the number of participants with an ADR. An adverse event (AE) was considered to be an ADR if either the physician who reported the AE, or the sponsor, assessed its causal relationship as 'related'. | From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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Non-interventional study in patients in Japan with chronic fibrosing ILDs with the progressive phenotype who are prescribed with Ofev and have never been treated with Ofev before; except patients with a diagnosis of idiopathic pulmonary fibrosis or patients with other chronic fibrosing ILDs with the progressive phenotype due to systemic sclerosis as the underlying disease. No limitations are set up on background factors and their concomitant drugs in use of actual medical practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | 1416017 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41718945 | Derived | Ito T, Shibuya A, Noguchi H. Safety and Tolerability of Nintedanib in Japanese Patients with Progressive Fibrosing Interstitial Lung Diseases: Final Results of 2-Year Post-Marketing Surveillance. Adv Ther. 2026 Apr;43(4):1723-1740. doi: 10.1007/s12325-026-03502-w. Epub 2026 Feb 20. |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
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.
425 patients were registered, Case Report Forms were collected for 409, and 1 was registered twice, so 408 patients started the treatment.
This was a non-interventional study based on newly collected data of patients under routine care to confirm safety of Ofev Capsules (nintedanib) in the real-world setting in Japanese patients with Progressive Fibrosing Interstitial Lung Disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ofev Capsules | Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ofev Capsules | Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022. |
| 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 | Incidence of Adverse Drug Reactions (ADRs) | Incidence of adverse drug reactions (ADRs) is reported as the number of participants with an ADR. An adverse event (AE) was considered to be an ADR if either the physician who reported the AE, or the sponsor, assessed its causal relationship as 'related'. | Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues. | Posted | Count of Participants | Participants | From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks. |
|
From first intake of Ofev Capsules prescribed at baseline visit and within 28 days (inclusive) after the last intake of Ofev Capsules, up to approximately 204 weeks.
Safety set: all patients who didn't have important protocol deviations regarding safety and regulatory issues.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ofev Capsules | Patients in Japan with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who were prescribed with Ofev Capsules and were never treated with Ofev Capsules before enrolment, were followed for up to 104 weeks or until discontinuation of administration. The enrollment took place from October 2020 to September 2022. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
Due to the nature of a single cohort observational study, there are issues that may impose limitations, in particular on the validity of the assessment based on the study data, such as selection bias, loss to follow up, channeling bias, and information and recall bias. Thus, comparisons and causal conclusions cannot be made, except for the investigator reported drug-related adverse events.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2024 | Jan 12, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 15, 2025 | Jan 12, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
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| Improved |
|
| No visit after last visit |
|
| No visit after last visit / Other personal reasons |
|
| Other personal reasons |
|
| Patient's wish |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 59 |
| 408 |
| 139 |
| 408 |
| 192 |
| 408 |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cor pulmonale | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
|
| Adrenal insufficiency | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
|
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Gastric antral vascular ectasia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pneumatosis intestinalis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Performance status decreased | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Physical deconditioning | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Cholangitis infective | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Cytomegalovirus viraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Enterocolitis viral | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Lung abscess | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Osteomyelitis chronic | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Pneumonia pseudomonal | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dermatomyositis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Immobilisation syndrome | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Bladder cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Colorectal adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Hepatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hepatic encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Parkinson's disease | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nephritis | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Microscopic polyangiitis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Peripheral circulatory failure | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Vascular pain | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | 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.