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Study to assess the long-term safety and effectiveness of Spiolto in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD) in real-world setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spiolto | Patient with COPD to received Spiolto |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spiolto | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Drug Reactions | Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes". | From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 | The COPD Assessment Testâ„¢ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions. |
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Inclusion criteria:
Exclusion criteria:
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1000
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35948844 | Derived | Sato A, Miyazaki A, Nakamura S. Effectiveness of Tiotropium/Olodaterol in the Real World: A Post Hoc Subgroup Analysis After the First Year of Use. Adv Ther. 2022 Oct;39(10):4692-4706. doi: 10.1007/s12325-022-02268-1. Epub 2022 Aug 10. |
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This non-randomized, post marketing surveillance (PMS) was a prospective study using a continuous investigation system. No specific criteria (e.g. demographic, baseline, concomitant drug in use) were defined for participant enrollment. Participants were enrolled from August 2016 to August 2017.
This was an observational study based on newly collected data under real-world practice in participants diagnosed with chronic obstructive pulmonary disease (COPD) (chronic bronchitis, emphysema) in Japan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Spiolto® | Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiolto® Respimat® excluding no visit after Spiolto® Respimat® administration.
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| ID | Title | Description |
|---|---|---|
| BG000 | Spiolto® | Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration. |
| 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 | Percentage of Participants With Adverse Drug Reactions | Percentage of participants with adverse drug reactions (ADR). An adverse drug reaction (ADR) is defined as an adverse event (AE) for which either the investigator or the sponsor (or both) assess the causal relationship to Spiolto® Respimat® as "Yes". | Safety set: This patient set includes all patients who were documented to have taken at least one dose of Spiolto® Respimat® excluding no visit after Spiolto® Respimat® administration. | Posted | Number | Percentage of participants (%) | From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks. |
|
From the first drug administration until 21 days after the last drug administration, up to approximately 82 weeks.
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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 | Spiolto® | Participants suffering from COPD were treated with a Fixed Dose Combination (FDC) of Tiotropium (Tio) 5 microgram (μg)/ + Olodaterol (Olo) 5 μg; solution for oral inhalation via Respimat® inhaler once daily, for 52 weeks or until discontinuation of administration. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.1 | Systematic Assessment |
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The study was conducted in an unblinded manner and without controls. The explanatory power of the study results was limited and the study results should be interpreted with the necessary caution.
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 29, 2018 | Nov 15, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 10, 2016 | Nov 15, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C000611386 | tiotropium-olodaterol |
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| Baseline and Week 12 |
| Lack of Efficacy |
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| Improvement in condition |
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| Lost to Follow-up |
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| Reason not listed |
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| 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 |
|
|
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| Secondary | Change of COPD Assessment Test (CAT) Score From Baseline to Week 12 | The COPD Assessment Test™ (CAT) is a short 8-item questionnaire for assessment and monitoring of COPD health status in routine practice. Its scale is 0-40 (high score = poor health). The CAT questionnaire has the advantage of a reduced number of items and could be used to assess the effects of inhaled therapies. The CAT score was the sum of the values corresponding to the answers to the eight questions. | Effectiveness set: The effectiveness set included all patients in the safety set except for those patients who had no any values of CAT, Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) after Spiolto® Respimat® administration. | Posted | Mean | Standard Deviation | Unit on a scale | Baseline and Week 12 |
|
|
|
| 38 |
| 1,273 |
| 94 |
| 1,273 |
| 0 |
| 1,273 |
| Cardiac failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Atrioventricular block second degree | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac failure chronic | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiovascular disorder | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Right ventricular failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Tracheo-oesophageal fistula | Congenital, familial and genetic disorders | MedDRA 21.1 | Systematic Assessment |
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| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
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| Thyrotoxic crisis | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Gastric ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Sudden death | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia bacterial | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Lung infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Infectious pleural effusion | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Compression fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| C-reactive protein increased | Investigations | MedDRA 21.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperphosphatasaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Lung adenocarcinoma recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Dementia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Asthma-chronic obstructive pulmonary disease overlap syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Aortic dissection | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |