Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:48 PM
Study NCT ID:
NCT00325403
Status:
COMPLETED
Last Update Posted:
2024-01-03
First Post:
2006-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C427248', 'term': 'treprostinil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'klaliberte@unither.com', 'phone': '919-425-8176', 'title': 'Kevin Laliberte; Senior Director, Product Development', 'organization': 'United Therapeutics Corporation'}, 'certainAgreement': {'otherDetails': 'Any publication of the results 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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded throughout the 12 week study which was conducted between October 2006 and April 2011.', 'description': 'Adverse events are reported for the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228).', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 68, 'seriousNumAtRisk': 77, 'deathsNumAffected': 6, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 138, 'seriousNumAtRisk': 151, 'deathsNumAffected': 9, 'seriousNumAffected': 27}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 131, 'numAffected': 95}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 54, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 50, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 31, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 25, 'numAffected': 23}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'upper abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 19, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'hemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'anterograde amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'collagen-vascular disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'cor pulmonale acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'diarrhea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'paroxysmal noturnal dypsnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'acute renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'systemic lupus erythematosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 77, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 151, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Six Minute Walk Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000', 'lowerLimit': '282', 'upperLimit': '381'}, {'value': '350', 'groupId': 'OG001', 'lowerLimit': '283', 'upperLimit': '386'}]}]}, {'title': '6MWD at Week 12', 'categories': [{'measurements': [{'value': '343', 'groupId': 'OG000', 'lowerLimit': '246', 'upperLimit': '403'}, {'value': '370', 'groupId': 'OG001', 'lowerLimit': '300', 'upperLimit': '418'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-5', 'groupId': 'OG000', 'lowerLimit': '-41', 'upperLimit': '49'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '-16', 'upperLimit': '63'}]}]}], 'analyses': [{'pValue': '0.0125', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23', 'ciLowerLimit': '4', 'ciUpperLimit': '41', 'pValueComment': 'P-Value', 'groupDescription': 'Using an allocation ratio of 2:1 between oral treprostinil and placebo, a fixed sample size of approximately 195 subjects with access to 0.25 mg tablets at randomization would provide at least 90% power at a significance level of 0.01 (two-sided hypothesis) to detect a between-treatment difference in the change from Baseline to Week 12 in distance traversed during the 6-minute walk, assuming a true underlying treatment difference of 45 meters with a SD of 75 meters in both treatment groups.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).\n\nThe six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000', 'lowerLimit': '282', 'upperLimit': '381'}, {'value': '350', 'groupId': 'OG001', 'lowerLimit': '283', 'upperLimit': '386'}]}]}, {'title': '6MWD at Week 11', 'categories': [{'measurements': [{'value': '335', 'groupId': 'OG000', 'lowerLimit': '254', 'upperLimit': '400'}, {'value': '350', 'groupId': 'OG001', 'lowerLimit': '290', 'upperLimit': '400'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 11', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-54', 'upperLimit': '36'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '-25', 'upperLimit': '50'}]}]}], 'analyses': [{'pValue': '0.0653', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13', 'ciLowerLimit': '-2', 'ciUpperLimit': '33', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 11', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration.\n\nThe six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000', 'lowerLimit': '282', 'upperLimit': '381'}, {'value': '350', 'groupId': 'OG001', 'lowerLimit': '283', 'upperLimit': '386'}]}]}, {'title': '6MWD at Week 8', 'categories': [{'measurements': [{'value': '347', 'groupId': 'OG000', 'lowerLimit': '240', 'upperLimit': '398'}, {'value': '355', 'groupId': 'OG001', 'lowerLimit': '300', 'upperLimit': '408'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-36', 'upperLimit': '35'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '54'}]}]}], 'analyses': [{'pValue': '0.0307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17', 'ciLowerLimit': '1', 'ciUpperLimit': '33', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 8', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).\n\nThe six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were conducted using the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Distance (6MWD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '339', 'groupId': 'OG000', 'lowerLimit': '282', 'upperLimit': '381'}, {'value': '350', 'groupId': 'OG001', 'lowerLimit': '283', 'upperLimit': '386'}]}]}, {'title': '6MWD at Week 4', 'categories': [{'measurements': [{'value': '350', 'groupId': 'OG000', 'lowerLimit': '254', 'upperLimit': '387'}, {'value': '360', 'groupId': 'OG001', 'lowerLimit': '285', 'upperLimit': '400'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-28', 'upperLimit': '17'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '42'}]}]}], 'analyses': [{'pValue': '0.0518', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12', 'ciLowerLimit': '0', 'ciUpperLimit': '24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).\n\nThe six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyses were conducted using the modified intention to treat (mITT), which includes subjects who had access to 0.25 mg tablets at randomization (n=228). All alpha was spent on this subgroup, thereby maintaining an overall type I error rate of 0.05. For sensitivity purposes, efficacy analyses were also performed on all enrolled subjects (n=349).'}, {'type': 'SECONDARY', 'title': 'Clinical Worsening Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:\n\n1. Death (all causes excluding accident)\n2. Transplantation or atrial septostomy\n3. Clinical deterioration as defined by:\n\n 1. Hospitalization as a result of PAH, or\n 2. greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And\n 3. Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'World Health Organization Functional Classification for PAH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': 'WHO Class I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'WHO Class II', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'WHO Class III', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'WHO Class IV', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7380', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '0', 'pValueComment': 'In cases where the "value corresponding to overall poorest relative change" was imputed for walk distance, a value of "IV" was used for the WHO functional classification for PAH.', 'estimateComment': 'The values for the estimated parameter and 95% confidence interval were calculated.', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 12', 'description': 'Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.\n\nClass III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with a WHO functional classification assessment at Week 12.'}, {'type': 'SECONDARY', 'title': 'Borg Dyspnea Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': 'Borg dyspnea score at Baseline', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '4'}]}]}, {'title': 'Borg dyspnea score at Week 12', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '5'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5'}]}]}, {'title': 'Change in Borg dyspnea score from Baseline to Wk12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '1'}]}]}], 'analyses': [{'pValue': '0.4887', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '-1', 'ciUpperLimit': '0', 'statisticalMethod': 'Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Dyspnea-Fatigue Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': 'Dyspnea-fatigue index at Baseline', 'categories': [{'measurements': [{'value': '5.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea-fatigue index at Week 12', 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Change in dyspnea-fatigue index from BL to Wk 12', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6116', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '1', 'statisticalMethod': 'Wilcoxon sum-rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two subjects (one in the placebo arm and one in the oral treprostinil arm) from the primary analysis population (n=228) did not have a Baseline dyspnea-fatigue index score and were not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Symptoms of PAH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': 'Change in fatigue symptoms', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Change in dyspnea symptoms', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change in edema symptoms', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Change in dizziness symptoms', 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Change in syncope symptoms', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Change in chest pain symptoms', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Change in orthopnea symptoms', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 12. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Six Minute Walk Distance by Baseline WHO Functional Classification III or IV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '333.5', 'groupId': 'OG000', 'lowerLimit': '269', 'upperLimit': '382.5'}, {'value': '330', 'groupId': 'OG001', 'lowerLimit': '265', 'upperLimit': '378'}]}]}, {'title': '6MWD at Week 12', 'categories': [{'measurements': [{'value': '316.5', 'groupId': 'OG000', 'lowerLimit': '231.5', 'upperLimit': '385'}, {'value': '354', 'groupId': 'OG001', 'lowerLimit': '265', 'upperLimit': '400'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-8.5', 'groupId': 'OG000', 'lowerLimit': '-50.5', 'upperLimit': '40'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '-20', 'upperLimit': '63'}]}]}], 'analyses': [{'pValue': '0.0326', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26', 'ciLowerLimit': '1', 'ciUpperLimit': '49', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Six Minute Walk Distance by Baseline WHO Functional Classification: I or II', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '370', 'groupId': 'OG000', 'lowerLimit': '297', 'upperLimit': '378'}, {'value': '366', 'groupId': 'OG001', 'lowerLimit': '315', 'upperLimit': '390'}]}]}, {'title': '6MWD at Week 12', 'categories': [{'measurements': [{'value': '379', 'groupId': 'OG000', 'lowerLimit': '274', 'upperLimit': '429'}, {'value': '391', 'groupId': 'OG001', 'lowerLimit': '348', 'upperLimit': '431'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 12', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '-30', 'upperLimit': '55'}, {'value': '27', 'groupId': 'OG001', 'lowerLimit': '-5', 'upperLimit': '67'}]}]}], 'analyses': [{'pValue': '0.2275', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.0', 'ciLowerLimit': '-15', 'ciUpperLimit': '47', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Exploratory efficacy analyses were to determine the effect of Baseline WHO functional class on treatment effect for change in 6MWD.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Six Minute Walk Distance (6MWD) by PAH Etiology: Idiopathic or Heritable PAH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '332.5', 'groupId': 'OG000', 'lowerLimit': '260', 'upperLimit': '379'}, {'value': '346', 'groupId': 'OG001', 'lowerLimit': '281', 'upperLimit': '390'}]}]}, {'title': '6MWD at Week 12', 'categories': [{'measurements': [{'value': '310.5', 'groupId': 'OG000', 'lowerLimit': '242.5', 'upperLimit': '380'}, {'value': '380', 'groupId': 'OG001', 'lowerLimit': '304', 'upperLimit': '420'}]}]}, {'title': 'Change in 6MWD from BL to Wk 12', 'categories': [{'measurements': [{'value': '-7.5', 'groupId': 'OG000', 'lowerLimit': '-50.5', 'upperLimit': '42'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '-13', 'upperLimit': '67'}]}]}], 'analyses': [{'pValue': '0.0024', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32', 'ciLowerLimit': '10', 'ciUpperLimit': '55', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Exploratory efficacy analyses were to determine the effect of PAH etiology (idiopathic/heritable, associated with collagen vascular disease, and other etiologies) on treatment effect for change in 6MWD.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'POST_HOC', 'title': 'Six Minute Walk Distance (6MWD) for the Entire Study Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '338.5', 'groupId': 'OG000', 'lowerLimit': '265.5', 'upperLimit': '383.5'}, {'value': '347', 'groupId': 'OG001', 'lowerLimit': '288', 'upperLimit': '387'}]}]}, {'title': '6MWD at Week 12', 'categories': [{'measurements': [{'value': '329.5', 'groupId': 'OG000', 'lowerLimit': '231.5', 'upperLimit': '397.5'}, {'value': '370', 'groupId': 'OG001', 'lowerLimit': '304', 'upperLimit': '420'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 12', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-46', 'upperLimit': '40'}, {'value': '25', 'groupId': 'OG001', 'lowerLimit': '-12', 'upperLimit': '63'}]}]}], 'analyses': [{'pValue': '0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.5', 'ciLowerLimit': '10', 'ciUpperLimit': '41', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 12', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data collected from all subjects enrolled in the study, regardless of tablet strength availability at randomization.\n\nThe six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Wk 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference i', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.'}, {'type': 'POST_HOC', 'title': 'Six Minute Walk Distance (6MWD) for the Entire Study Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '338.5', 'groupId': 'OG000', 'lowerLimit': '265.5', 'upperLimit': '383.5'}, {'value': '347', 'groupId': 'OG001', 'lowerLimit': '288', 'upperLimit': '387'}]}]}, {'title': '6MWD at Week 11', 'categories': [{'measurements': [{'value': '326.5', 'groupId': 'OG000', 'lowerLimit': '206', 'upperLimit': '398'}, {'value': '351', 'groupId': 'OG001', 'lowerLimit': '303', 'upperLimit': '403'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 11', 'categories': [{'measurements': [{'value': '-2', 'groupId': 'OG000', 'lowerLimit': '-58.5', 'upperLimit': '36'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-18', 'upperLimit': '48'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17', 'ciLowerLimit': '3', 'ciUpperLimit': '33', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 11', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration. This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at the time of randomization.\n\nThe six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.'}, {'type': 'POST_HOC', 'title': 'Six Minute Walk Distance (6MWD) for the Entire Study Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '338.5', 'groupId': 'OG000', 'lowerLimit': '265.5', 'upperLimit': '383.5'}, {'value': '347', 'groupId': 'OG001', 'lowerLimit': '288', 'upperLimit': '387'}]}]}, {'title': '6MWD at Week 8', 'categories': [{'measurements': [{'value': '339.5', 'groupId': 'OG000', 'lowerLimit': '227', 'upperLimit': '392'}, {'value': '360', 'groupId': 'OG001', 'lowerLimit': '300', 'upperLimit': '411'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 8', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-38.5', 'upperLimit': '34.5'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '-13', 'upperLimit': '54'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20', 'ciLowerLimit': '7', 'ciUpperLimit': '34', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 8', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.\n\nThe six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.'}, {'type': 'POST_HOC', 'title': 'Six Minute Walk Distance (6MWD) for the Entire Study Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily.'}, {'id': 'OG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily.'}], 'classes': [{'title': '6MWD at Baseline', 'categories': [{'measurements': [{'value': '338.5', 'groupId': 'OG000', 'lowerLimit': '265.5', 'upperLimit': '383.5'}, {'value': '347', 'groupId': 'OG001', 'lowerLimit': '288', 'upperLimit': '387'}]}]}, {'title': '6MWD at Week 4', 'categories': [{'measurements': [{'value': '339.5', 'groupId': 'OG000', 'lowerLimit': '251', 'upperLimit': '387'}, {'value': '358', 'groupId': 'OG001', 'lowerLimit': '288', 'upperLimit': '403.2'}]}]}, {'title': 'Change in 6MWD from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-31.5', 'upperLimit': '20'}, {'value': '7', 'groupId': 'OG001', 'lowerLimit': '-13', 'upperLimit': '42'}]}]}], 'analyses': [{'pValue': '0.0025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hodges-Lehmann (H-L)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14', 'ciLowerLimit': '3.9', 'ciUpperLimit': '25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 4', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). This outcome measure was assessed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.\n\nThe six minute walk test was to be conducted 3 to 6 house after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.', 'unitOfMeasure': 'meters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis was performed using data from all subjects enrolled in the study, regardless of tablet strength availability at randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive matching oral placebo twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.'}, {'id': 'FG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '116'}, {'groupId': 'FG001', 'numSubjects': '233'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '98 subjects receiving placebo completed the study on study drug', 'groupId': 'FG000', 'numSubjects': '98'}, {'comment': '182 subjects receiving oral treprostinil completed the study on study drug', 'groupId': 'FG001', 'numSubjects': '182'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '51'}]}]}], 'recruitmentDetails': '349 subjects participated in the study from 24 October 2006 to 29 April 2011 at 52 of 77 sites across the United States, Puerto Rico, Canada, Europe, Israel, India, Mexico, and China. The primary endpoint was analyzed using the primary analysis population which included 228 subjects who had access to 0.25 mg tablets at the time of randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population. Baseline measures are provided for the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228).'}, {'id': 'BG001', 'title': 'UT-15C (Oral Treprostinil)', 'description': 'These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population. Baseline measures are provided for the modified intention to treat (mITT) group, which includes subjects with access to 0.25 mg tablets at randomization (n=228).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '210', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '37.8', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '39.4', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'PAH Etiology', 'classes': [{'title': 'Idiopathic or heritable PAH', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '170', 'groupId': 'BG002'}]}]}, {'title': 'PAH associated w collagen vascular disease', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'PAH associated w repaired congenital heart defect', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'PAH associated w HIV infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Six Minute Walk Distance', 'classes': [{'categories': [{'measurements': [{'value': '327.6', 'spread': '70.7', 'groupId': 'BG000'}, {'value': '331.3', 'spread': '64.9', 'groupId': 'BG001'}, {'value': '330.0', 'spread': '66.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WHO Functional Classification', 'classes': [{'title': 'WHO Class I', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'WHO Class II', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'WHO Class III', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '98', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Class I: PH without limitation of physical activity (PA); no undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass II: PH resulting in slight limitation of PA; comfortable at rest; ordinary PA causes undue dyspnea or fatigue, chest pain or near syncope.\n\nClass III: PH resulting in marked limitation of PA; comfortable at rest; ordinary PA causes undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass IV: PH with inability to carry out any PA without symptoms and signs of right heart failure. Dyspnea and/or fatigue may be present at rest. Discomfort is increased by any PA.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 349}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-12', 'studyFirstSubmitDate': '2006-05-11', 'resultsFirstSubmitDate': '2013-01-03', 'studyFirstSubmitQcDate': '2006-05-11', 'lastUpdatePostDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-02-12', 'studyFirstPostDateStruct': {'date': '2006-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six Minute Walk Distance (6MWD)', 'timeFrame': 'Baseline and Week 12', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 12, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).\n\nThe six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 12. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.'}], 'secondaryOutcomes': [{'measure': 'Six Minute Walk Distance (6MWD)', 'timeFrame': 'Baseline and Week 11', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 11, a time expected to correlate with trough treprostinil concentration.\n\nThe six minute walk test was to be conducted 8 to 13 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 11. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.'}, {'measure': 'Six Minute Walk Distance (6MWD)', 'timeFrame': 'Baseline and Week 8', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 8, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).\n\nThe six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 8. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.'}, {'measure': 'Six Minute Walk Distance (6MWD)', 'timeFrame': 'Baseline and Week 4', 'description': 'Placebo corrected change in six minute walk distance (6MWD) from Baseline to Week 4, correlates with the historical clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS).\n\nThe six minute walk test was to be conducted 3 to 6 hours after the previous dose of study drug.\n\nThe Hodges-Lehmann median difference between treatment groups was used to estimate the treatment effect on 6MWD from Baseline to Week 4. A rank-based methodology was used instead of parametric-based methodology to avoid statistical bias caused by extreme outliers resulting from the handling of data that are missing due to death or clinical worsening of PAH. It is a more robust estimator than the between-treatment difference in medians.'}, {'measure': 'Clinical Worsening Assessment', 'timeFrame': 'Baseline and Week 12', 'description': 'Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:\n\n1. Death (all causes excluding accident)\n2. Transplantation or atrial septostomy\n3. Clinical deterioration as defined by:\n\n 1. Hospitalization as a result of PAH, or\n 2. greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And\n 3. Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)'}, {'measure': 'World Health Organization Functional Classification for PAH', 'timeFrame': 'Baseline and Week 12', 'description': 'Class I: Patients with pulmonary hypertension but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass II: Patients with pulmonary hypertension resulting in slight limitation of physical activity. These patients are comfortable at rest, but ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope.\n\nClass III: Patients with pulmonary hypertension resulting in marked limitation of physical activity. They are comfortable at rest. Ordinary activity causes undue dyspnea or fatigue, chest pain, or near syncope.\n\nClass IV: Patients with pulmonary hypertension with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may be present even at rest. Discomfort is increased by any physical activity.'}, {'measure': 'Borg Dyspnea Score', 'timeFrame': 'Baseline and Week 12', 'description': 'The Borg dyspnea score is a 10-point scale rating the maximum level of dyspnea experienced during the 6-minute walk test. The Borg dyspnea score was assessed immediately following the 6-minute walk test. Scores ranged from 0 (for no shortness of breath) to 10 (for greatest shortness of breath ever experienced).'}, {'measure': 'Dyspnea-Fatigue Index', 'timeFrame': 'Baseline and Week 12', 'description': 'The dyspnea-fatigue index has three components, each rated on a scale of 0 to 4, for the magnitude of the task that evokes dyspnea or fatigue, the magnitude of the pace (or effort) with which the task is performed and the associated functional impairment in general activities. The ratings for each component were added to form an aggregate score, which could range from 0, for the worst condition, to 12, for the best.'}, {'measure': 'Symptoms of PAH', 'timeFrame': 'Baseline and Week 12', 'description': 'Defined symptoms of PAH including fatigue, dyspnea, edema, dizziness, syncope, chest pain, and orthopnea were assessed at Baseline prior to starting study drug and during the Treatment Phase at Week 12. Severity grade values (i.e., 0, 1, 2, or 3 in increasing severity) were assigned for each symptom.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary Arterial Hypertension'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '23307827', 'type': 'DERIVED', 'citation': 'Jing ZC, Parikh K, Pulido T, Jerjes-Sanchez C, White RJ, Allen R, Torbicki A, Xu KF, Yehle D, Laliberte K, Arneson C, Rubin LJ. Efficacy and safety of oral treprostinil monotherapy for the treatment of pulmonary arterial hypertension: a randomized, controlled trial. Circulation. 2013 Feb 5;127(5):624-33. doi: 10.1161/CIRCULATIONAHA.112.124388. Epub 2013 Jan 10.'}], 'seeAlsoLinks': [{'url': 'http://www.pahstudy.com', 'label': 'FREEDOM Studies Website'}]}, 'descriptionModule': {'briefSummary': 'This study was an international, multicenter, randomized (2:1 active:placebo), double-blind, placebo-controlled study in subjects with PAH who were NOT currently receiving approved therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test. Study procedures included routine blood tests, medical history, physical exams, disease evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at select centers - a hemodynamic substudy with a right heart catheterization at Baseline and Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and Week 12.\n\nPatients who completed all assessments for 12 weeks were also eligible to enter an open-label, extension phase study (FREEDOM - EXT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 12 and 75 years of age, inclusive.\n* Body weight at least 40 kg with a Body Mass Index \\< 45\n* PAH that is either idiopathic/heritable; associated with repaired congenital systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular disease; associated with HIV.\n* Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.\n* Baseline 6-minute walk distance between 200 and 425 meters, inclusive.\n* Reliable and cooperative with protocol requirements.\n\nExclusion Criteria:\n\n* Nursing or pregnant.\n* Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5 inhibitor, or prostacyclin within 30 days of Baseline.\n* PAH due to conditions other than noted in the above inclusion criteria.\n* History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart disease, uncontrolled systemic hypertension, or parenchymal lung disease.\n* Use of an investigational drug within 30 days of Baseline.'}, 'identificationModule': {'nctId': 'NCT00325403', 'briefTitle': 'FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'United Therapeutics'}, 'officialTitle': 'A 12-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': 'TDE-PH-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'UT-15C (oral treprositnil)', 'description': 'Subjects receive UT-15C (oral treprostinil) twice daily.', 'interventionNames': ['Drug: Oral treprostinil (UT-15C) Sustained Release Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects receive placebo (sugar pill) twice daily.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Oral treprostinil (UT-15C) Sustained Release Tablets', 'type': 'DRUG', 'otherNames': ['treprostinil diethanolamine'], 'description': 'Sustained release oral tablet, twice daily', 'armGroupLabels': ['UT-15C (oral treprositnil)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo oral tablet twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama-Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Pulmonary Specialist', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Arizona', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco-Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'West Los Angeles VA Healthcare Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Science Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida - Shands Hospital', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'city': 'Weston', 'state': 'Florida', 'country': 'United States', 'facility': 'Cleveland Clinic Florida', 'geoPoint': {'lat': 26.10037, 'lon': -80.39977}}, {'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Hospitals', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospital and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Kentuckiana Pulmonary Associates', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Alexandria Cardiology Clinic', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Newark Beth Israel Medical Center', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Presbyterian Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Mary M Parkes Center for Asthma, Allergy and Pulmonary Care - University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Lindner Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Clinic Northwest', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine, Pulmonary & Critical Care', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Heart Care Associates', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Vienna', 'country': 'Austria', 'facility': 'Universitaet Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hospital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Peter Lougheed Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Science Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'SMBD Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Beijing Shijitan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Clamart', 'country': 'France', 'facility': 'Hospital Antoine Beclere', 'geoPoint': {'lat': 48.80299, 'lon': 2.26692}}, {'city': 'Hyderbad', 'state': 'Andhra Pradesh', 'country': 'India', 'facility': 'PRIME Hospitals'}, {'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Care Institute of Medical Science', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Lifecare 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