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A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tyvaso | The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care. |
| |
| Control | The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled prostacyclin | Drug | Tyvaso |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of Respiratory Tract-Related Adverse Events of Interest | Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study. | Follow-up every 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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community centers, academic institutions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Associates, P.C. | Birmingham | Alabama | 35213 | United States | ||
| The University of Alabama at Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27683610 | Derived | Zamanian RT, Levine DJ, Bourge RC, De Souza SA, Rosenzweig EB, Alnuaimat H, Burger C, Mathai SC, Leedom N, DeAngelis K, Lim A, De Marco T. An observational study of inhaled-treprostinil respiratory-related safety in patients with pulmonary arterial hypertension. Pulm Circ. 2016 Sep;6(3):329-37. doi: 10.1086/688059. |
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The recruitment period for this study was February 2010 to December 2014. All sites were located in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tyvaso | The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care. inhaled prostacyclin: Tyvaso |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| inhaled prostacyclin | Drug | As prescribed by the physician |
|
|
| prostacyclin | Drug | As prescribed by the physician |
|
|
| subcutaneous and intravenous prostacyclin | Drug | As prescribed by physician |
|
|
| oral ERA | Drug | As prescribed by physician |
|
|
| oral PDE5 inhibitors | Drug | As prescribed by physician |
|
|
| Birmingham |
| Alabama |
| 35294 |
| United States |
| University of South Alabama | Mobile | Alabama | 36693 | United States |
| Arizona Pulmonary Specialists, LTD | Phoenix | Arizona | 85013 | United States |
| Berkeley Cardiovascular Medical Group | Berkeley | California | 94705 | United States |
| Cedars-Sinai Heart Institute | Beverly Hills | California | 90211 | United States |
| University California San Francisco | Fresno | California | 93721 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| West Los Angeles VA Healthcare Center | Los Angeles | California | 90073 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Paloma Medical Group | San Juan Capistrano | California | 92675 | United States |
| Santa Barbara Cottage Hospital | Santa Barbara | California | 93105 | United States |
| Stanford Hospital and Clinics | Stanford | California | 94305 | United States |
| Children's Hospital Denver | Denver | Colorado | 80045 | United States |
| Western States Clinical Research, Inc. | Wheat Ridge | Colorado | 80033 | United States |
| St. Francis Sleep Allergy & Lung | Clearwater | Florida | 33765 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Pulmonary and Critical Care Associates | Jacksonville | Florida | 32204 | United States |
| University of Florida College of Medicine Jacksonville | Jacksonville | Florida | 32209 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32224 | United States |
| Miami Center for Cardiovascular Disease | Miami | Florida | 33136 | United States |
| Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Central Florida Pulmonary Group, P.A. | Orlando | Florida | 32806 | United States |
| Orlando Heart Center | Orlando | Florida | 32806 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Emory University School of Medicine | Atlanta | Georgia | 30322 | United States |
| Georgia Lung Associates, PC | Austell | Georgia | 30106 | United States |
| Northwestern Medical Center | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Midwest Heart Foundation | Oakbrook Terrace | Illinois | 60181 | United States |
| Indiana University Hospital | Carmel | Indiana | 46032 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Mercy Hospital | Iowa City | Iowa | 52245 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Kentuckiana Pulmonary Associates | Louisville | Kentucky | 40202 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States |
| Tufts - New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| William Beaumont Hospital | Troy | Michigan | 48085 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Nebraska Pulmonary Specialties, LLC | Lincoln | Nebraska | 68506 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center | New Brunswick | New Jersey | 08903 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| SUNY Stony Brook University Medical Center | Islandia | New York | 11790 | United States |
| Winthrop Pulmonary Associates | Mineola | New York | 11501 | United States |
| North Shore - Long Island Jewish Health System | New Hyde Park | New York | 11040 | United States |
| St. Luke's-Roosevelt Hospital Center | New York | New York | 10019 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Mary M Parkes Center | Rochester | New York | 14623 | United States |
| Pulmonary Health Physicians | Syracuse | New York | 13210 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Pinehurst Medical Clinic | Pinehurst | North Carolina | 28374 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Akron General Hospital | Akron | Ohio | 44302 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267-0564 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Davis Heart and Lung Research Institute | Columbus | Ohio | 43210 | United States |
| Mercy Fairfield Hospital | Fairfield | Ohio | 45014 | United States |
| Legacy Pulmonary Northwest | Portland | Oregon | 97210 | United States |
| Oregon Clinic, PC | Portland | Oregon | 97220 | United States |
| OHSU-Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213-2582 | United States |
| Berks Schuylkill Respiratory Specialists, Ltd. | Wyomissing | Pennsylvania | 19610 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Lexington Pulmonary and Critical Care | Lexington | South Carolina | 29072 | United States |
| MD Total Care, PLLC | Chattanooga | Tennessee | 37419 | United States |
| Summit Medical Group | Knoxville | Tennessee | 37909 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | United States |
| Aurora Health Care | Milwaukee | Wisconsin | 53215 | United States |
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.
inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tyvaso | The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care. inhaled prostacyclin: Tyvaso |
| BG001 | Control | The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Disease etiology | Patients were instructed to select all that apply. | Number | participants |
| |||||||||||||||
| Race | Patients were instructed to select all that apply. | Number | participants |
| |||||||||||||||
| Years Since PAH Diagnosis | Median | Full Range | years |
| |||||||||||||||
| Baseline PAH Medication | Patients were instructed to select all that apply. | Number | participants |
|
| 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 | Prevalence of Respiratory Tract-Related Adverse Events of Interest | Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study. | Posted | Number | percentage of participants | Follow-up every 3 months |
|
|
|
Respiratory tract-related AEs were recorded from the time of informed consent to study completion or discontinuation.
SAEs were included in the "Other" AE table because one participant may have experienced both an SAE and non-serious AE during the study. Non-respiratory-related AEs and SAEs were outside the scope of this study.
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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 | Tyvaso | The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care. inhaled prostacyclin: Tyvaso | 96 | 666 | 403 | 666 | ||
| EG001 | Control | The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care. | 94 | 667 | 388 | 667 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Lobar pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia viral | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchitis viral | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Parainfluenza virus infection | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Lupus pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Cellulitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Chronic sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| H1N1 influenza | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Lung adenocarcinoma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Metapneumovirus infection | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia streptococcal | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory tract hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Chronic respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Acute sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia bacterial | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia haemophilus | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia staphylococcal | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory syncytial virus test positive | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Rhinovirus infection | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Tracheobronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Sinusitis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Non-systematic Assessment |
|
Any publication of the result of this trial must be consistent with the United Therapeutics publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Leedom | United Therapeutics Corporation | 919-425-5870 | nleedom@unither.com |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C427248 | treprostinil |
| D016285 | Iloprost |
| D011464 | Epoprostenol |
| D007279 | Injections, Subcutaneous |
| D000077300 | Bosentan |
| C467894 | ambrisentan |
| D058986 | Phosphodiesterase 5 Inhibitors |
| D000068677 | Sildenafil Citrate |
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D044062 | Prostaglandins I |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010726 | Phosphodiesterase Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D010879 | Piperazines |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002243 | Carbolines |
| D011725 | Pyridines |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006575 | Heterocyclic Compounds, 3-Ring |
Not provided
Not provided
| Male |
|
| Connective tissue disease |
|
| Congential heart disease |
|
| HIV infection/porto-pulmonary |
|
| Other |
|
| Black/African American |
|
| Other/race not disclosed |
|
| Asian |
|
| Native Hawaiian/Pacific Islander |
|
| American Indian/Alaska Native |
|
| Remodulin (treprostinil) |
|
| Flolan (epoprostenol) |
|
| Veletri (epoprostinol) |
|
| Ventavis (iloprost) inhalation |
|
| Revatio (sildenafil citrate) |
|
| Adcirca (tadalafil) |
|
| Letairis (ambrisentan) |
|
| Tracleer (bosentan) |
|
| Opsumit (macitentan) |
|
| Adempas (riociguat) |
|
| Irritation/pain of nose, mouth, larynx, pharynx |
|
| Upper or lower respiratory tract infection |
|
| Wheezing, bronchospasm, or asthma/COPD exacerbate |
|