Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-28 @ 9:14 AM
Study NCT ID:
NCT00477269
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2007-05-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
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However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Core - STI571', 'description': 'Core - STI571', 'otherNumAtRisk': 28, 'otherNumAffected': 26, 'seriousNumAtRisk': 28, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Core - Placebo', 'description': 'Core - Placebo', 'otherNumAtRisk': 31, 'otherNumAffected': 25, 'seriousNumAtRisk': 31, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Extension - STI571', 'description': 'Extension - STI571', 'otherNumAtRisk': 22, 'otherNumAffected': 21, 'seriousNumAtRisk': 22, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 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'numAffected': 8}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Exercise tolerance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 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{'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 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{'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Musculoskeletal pain', 'stats': 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28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, 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'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Arterial rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 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See Safety Section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population all participants enrolled was included in this population'}, {'type': 'PRIMARY', 'title': 'Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Patients', 'description': 'Open label extension'}], 'classes': [{'title': 'Any AE(s)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'SAE(s)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '72 months', 'description': 'In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'No formal statistical analysis was performed in the extension phase of this study so no analysis data sets were defined. All summaries are based on all patients enrolled.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Day 32 (n=25,27)', 'categories': [{'measurements': [{'value': '10.2', 'spread': '53.7', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'week 8 (n=23,24)', 'categories': [{'measurements': [{'value': '17.0', 'spread': '55.6', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '40.8', 'groupId': 'OG001'}]}]}, {'title': 'week 12 (n=22,24)', 'categories': [{'measurements': [{'value': '21', 'spread': '36.2', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'week 16 (n=19, 23)', 'categories': [{'measurements': [{'value': '25.5', 'spread': '43.1', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '47.9', 'groupId': 'OG001'}]}]}, {'title': 'week 20 (n=19, 21)', 'categories': [{'measurements': [{'value': '38.3', 'spread': '42.5', 'groupId': 'OG000'}, {'value': '12.8', 'spread': '60.4', 'groupId': 'OG001'}]}]}, {'title': 'study completion Week 24 (n=21, 12)', 'categories': [{'measurements': [{'value': '22.0', 'spread': '63.1', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '53.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance \\<500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance \\>800 meters (with no rests) suggests mild or no limitation.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Day 32 (n=25,27)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'week 8 (n=23,24)', 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'week 12 (n=22,24)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'week 16 (n=19, 23)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'week 20 (n=19, 21)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'study completion Week 24 (n=21, 12)', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient.', 'unitOfMeasure': 'number of stops', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Day 32 (n=25,27)', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': 'week 8 (n=23,24)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'week 12 (n=22,24)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'week 16 (n=19, 23)', 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.26', 'groupId': 'OG001'}]}]}, {'title': 'week 20 (n=19, 21)', 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'study completion Week 24 (n=21, 12)', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline: WHO Class IV (n=27,30)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: WHO Class III (n=27,30)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: WHO Class II (n=27,30)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: WHO Class IV (n=27,30)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: WHO Class III (n=27,30)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: WHO Class II (n=27,30)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: WHO Class IV (n=24,27)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: WHO Class III (n=24,27)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: WHO Class II (n=24,27)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: WHO Class IV (n=23,27)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: WHO Class III (n=23,27)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: WHO Class II (n=23,27)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: WHO Class IV (n=22,27)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: WHO Class III (n=22,27)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: WHO Class II (n=22,27)', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: WHO Class I (n=22,27)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: WHO Class IV (n=19,24)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: WHO Class III (n=19,24)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: WHO Class II (n=19,24)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: WHO Class I (n=19,24)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: WHO Class IV (n=21,25)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: WHO Class III (n=21,25)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: WHO Class II (n=21,25)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion', 'description': 'PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline: Resting (n= 28, 29)', 'categories': [{'measurements': [{'value': '94.3', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '93.4', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: End of Test (n= 28, 28)', 'categories': [{'measurements': [{'value': '87.9', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '87.9', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2 minutes after end of test (n=26, 26)', 'categories': [{'measurements': [{'value': '93.0', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '92.0', 'spread': '6.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: Resting (n= 25, 28)', 'categories': [{'measurements': [{'value': '94.5', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '92.4', 'spread': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: End of Test (n= 25, 28)', 'categories': [{'measurements': [{'value': '89.0', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '87.2', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: 2 minutes after end of test (n= 25, 26)', 'categories': [{'measurements': [{'value': '94.8', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '92.7', 'spread': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: Resting (n= 23, 25)', 'categories': [{'measurements': [{'value': '95.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '93.2', 'spread': '6.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: End of Test (n= 23, 24)', 'categories': [{'measurements': [{'value': '90.9', 'spread': '6.7', 'groupId': 'OG000'}, {'value': '87.9', 'spread': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: 2 minutes after end of test (n= 23, 23)', 'categories': [{'measurements': [{'value': '94.4', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '93.1', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Resting (n= 22, 25)', 'categories': [{'measurements': [{'value': '95.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '93.9', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: End of Test (n= 20, 24)', 'categories': [{'measurements': [{'value': '89.8', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '89.6', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 minutes after end of test (n= 19, 22)', 'categories': [{'measurements': [{'value': '92.7', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '94.2', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: Resting (n= 19, 24)', 'categories': [{'measurements': [{'value': '95.0', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '94.1', 'spread': '5.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: End of Test (n= 18, 23)', 'categories': [{'measurements': [{'value': '87.9', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '88.1', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: 2 minutes after end of test (n= 19, 19)', 'categories': [{'measurements': [{'value': '94.6', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '93.3', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: Resting (n= 19, 22)', 'categories': [{'measurements': [{'value': '94.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '93.7', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: End of Test (n= 18, 21)', 'categories': [{'measurements': [{'value': '87.5', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '87.6', 'spread': '9.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: 2 minutes after end of test (n= 19, 21)', 'categories': [{'measurements': [{'value': '93.8', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '93.4', 'spread': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Resting (n= 20, 22)', 'categories': [{'measurements': [{'value': '95.5', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '94.3', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: End of Test (n= 20, 21)', 'categories': [{'measurements': [{'value': '89.9', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '89.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 minutes after end of test (n= 20, 21)', 'categories': [{'measurements': [{'value': '94.8', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '94.8', 'spread': '3.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%.', 'unitOfMeasure': 'Percentage of Oxygen Saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline: Resting (n= 26, 28)', 'categories': [{'measurements': [{'value': '111.3', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '104.6', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: End of Test (n= 21, 26)', 'categories': [{'measurements': [{'value': '119.9', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '118.3', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2 minutes after end of test (n=25, 27)', 'categories': [{'measurements': [{'value': '120.0', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '110.4', 'spread': '13.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: Resting (n= 25, 27)', 'categories': [{'measurements': [{'value': '111.4', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '106.0', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: End of Test (n= 22, 22)', 'categories': [{'measurements': [{'value': '126.5', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '122.3', 'spread': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: 2 minutes after end of test (n= 25, 26)', 'categories': [{'measurements': [{'value': '119.6', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '113.8', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: Resting (n= 22, 24)', 'categories': [{'measurements': [{'value': '108.9', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '107.3', 'spread': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: End of Test (n= 19, 20)', 'categories': [{'measurements': [{'value': '124.6', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '119.9', 'spread': '17.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: 2 minutes after end of test (n= 23, 24)', 'categories': [{'measurements': [{'value': '115.2', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '114.5', 'spread': '13.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Resting (n= 22, 23)', 'categories': [{'measurements': [{'value': '106.5', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '107.7', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: End of Test (n= 17, 19)', 'categories': [{'measurements': [{'value': '122.2', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '118.8', 'spread': '22.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 minutes after end of test (n= 20, 22)', 'categories': [{'measurements': [{'value': '115.9', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '115.9', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: Resting (n= 19, 22)', 'categories': [{'measurements': [{'value': '106.7', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '105.7', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: End of Test (n= 15,18)', 'categories': [{'measurements': [{'value': '117.2', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '119.8', 'spread': '13.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: 2 minutes after end of test (n= 19, 22)', 'categories': [{'measurements': [{'value': '114.6', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '112.6', 'spread': '15.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: Resting (n= 19, 20)', 'categories': [{'measurements': [{'value': '106.5', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '109.1', 'spread': '12.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: End of Test (n= 16,17)', 'categories': [{'measurements': [{'value': '122.4', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '119.9', 'spread': '19.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: 2 minutes after end of test (n= 19, 20)', 'categories': [{'measurements': [{'value': '115.5', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '115.1', 'spread': '15.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Resting (n= 20, 21)', 'categories': [{'measurements': [{'value': '110.6', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '108.2', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: End of Test (n= 16, 17)', 'categories': [{'measurements': [{'value': '126.9', 'spread': '23.6', 'groupId': 'OG000'}, {'value': '116.8', 'spread': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 minutes after end of test (n= 20, 19)', 'categories': [{'measurements': [{'value': '118.2', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '111.1', 'spread': '10.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline: Resting (n= 26, 28)', 'categories': [{'measurements': [{'value': '68.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '67.9', 'spread': '8.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: End of Test (n= 21, 26)', 'categories': [{'measurements': [{'value': '75.1', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '69.5', 'spread': '11.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2 minutes after end of test (n=25, 27)', 'categories': [{'measurements': [{'value': '71.6', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '67.9', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: Resting (n= 25, 27)', 'categories': [{'measurements': [{'value': '69.6', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '68.4', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: End of Test (n= 22, 22)', 'categories': [{'measurements': [{'value': '78.2', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '75.2', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: 2 minutes after end of test (n= 25, 26)', 'categories': [{'measurements': [{'value': '72.5', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: Resting (n= 22, 24)', 'categories': [{'measurements': [{'value': '67.7', 'spread': '11.8', 'groupId': 'OG000'}, {'value': '68.8', 'spread': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: End of Test (n= 19, 20)', 'categories': [{'measurements': [{'value': '74.8', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '74.0', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: 2 minutes after end of test (n= 23, 24)', 'categories': [{'measurements': [{'value': '71.2', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '72.2', 'spread': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Resting (n= 22, 23)', 'categories': [{'measurements': [{'value': '65.5', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '70.6', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: End of Test (n= 17, 19)', 'categories': [{'measurements': [{'value': '75.6', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '72.4', 'spread': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 minutes after end of test (n= 20, 22)', 'categories': [{'measurements': [{'value': '73.1', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '72.0', 'spread': '13.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: Resting (n= 19, 22)', 'categories': [{'measurements': [{'value': '67.7', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '66.7', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: End of Test (n= 15,18)', 'categories': [{'measurements': [{'value': '72.7', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '76.7', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: 2 minutes after end of test (n= 19, 22)', 'categories': [{'measurements': [{'value': '71.4', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '70.5', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: Resting (n= 19, 20)', 'categories': [{'measurements': [{'value': '67.2', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '69.8', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: End of Test (n= 16,17)', 'categories': [{'measurements': [{'value': '72.9', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: 2 minutes after end of test (n= 19, 20)', 'categories': [{'measurements': [{'value': '71.9', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '72.7', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Resting (n= 20, 21)', 'categories': [{'measurements': [{'value': '69.7', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '70.7', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: End of Test (n= 16, 17)', 'categories': [{'measurements': [{'value': '74.1', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '72.3', 'spread': '10.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 minutes after end of test (n= 20, 19)', 'categories': [{'measurements': [{'value': '71.3', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '72.9', 'spread': '9.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline: Resting (n= 28, 29)', 'categories': [{'measurements': [{'value': '80.8', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '87.9', 'spread': '12.7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: End of Test (n= 28, 29)', 'categories': [{'measurements': [{'value': '106.3', 'spread': '23.9', 'groupId': 'OG000'}, {'value': '112.3', 'spread': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2 minutes after end of test (n=26, 26)', 'categories': [{'measurements': [{'value': '84.2', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '94.1', 'spread': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: Resting (n= 25, 28)', 'categories': [{'measurements': [{'value': '80.7', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '83.6', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: End of Test (n= 25, 28)', 'categories': [{'measurements': [{'value': '108.4', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '113.1', 'spread': '19.5', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: 2 minutes after end of test (n= 25, 26)', 'categories': [{'measurements': [{'value': '89.2', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '90.6', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: Resting (n= 23, 25)', 'categories': [{'measurements': [{'value': '80.3', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '81.1', 'spread': '11.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: End of Test (n= 23, 24)', 'categories': [{'measurements': [{'value': '109.5', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '110.3', 'spread': '26.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: 2 minutes after end of test (n= 23, 23)', 'categories': [{'measurements': [{'value': '85.3', 'spread': '15.7', 'groupId': 'OG000'}, {'value': '88.9', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Resting (n= 22, 25)', 'categories': [{'measurements': [{'value': '76.5', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '85.1', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: End of Test (n= 20, 25)', 'categories': [{'measurements': [{'value': '105.3', 'spread': '26.2', 'groupId': 'OG000'}, {'value': '113.0', 'spread': '26.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 minutes after end of test (n= 19, 22)', 'categories': [{'measurements': [{'value': '83.8', 'spread': '17.8', 'groupId': 'OG000'}, {'value': '89.4', 'spread': '15.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: Resting (n= 19, 24)', 'categories': [{'measurements': [{'value': '76.5', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '84.4', 'spread': '12.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: End of Test (n= 18, 23)', 'categories': [{'measurements': [{'value': '102.8', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '117.9', 'spread': '24.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: 2 minutes after end of test (n= 19, 21)', 'categories': [{'measurements': [{'value': '85.8', 'spread': '21.0', 'groupId': 'OG000'}, {'value': '85.5', 'spread': '14.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: Resting (n= 19, 22)', 'categories': [{'measurements': [{'value': '75.3', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '80.2', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: End of Test (n= 18,22)', 'categories': [{'measurements': [{'value': '109.2', 'spread': '26.8', 'groupId': 'OG000'}, {'value': '118.0', 'spread': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: 2 minutes after end of test (n= 19, 21)', 'categories': [{'measurements': [{'value': '83.3', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '87.3', 'spread': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Resting (n= 20, 22)', 'categories': [{'measurements': [{'value': '79.5', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '83.6', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: End of Test (n= 20, 21)', 'categories': [{'measurements': [{'value': '110.2', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '116.8', 'spread': '21.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 minutes after end of test (n= 20, 21)', 'categories': [{'measurements': [{'value': '87.9', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '88.9', 'spread': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Borg Score During the Six Minutes Walk Test at Different Time Periods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline: Resting (n= 26, 27)', 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: End of Test (n= 27, 29)', 'categories': [{'measurements': [{'value': '3.34', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '1.59', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: 2 minutes after end of test (n=24, 26)', 'categories': [{'measurements': [{'value': '0.88', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '1.47', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: Resting (n= 25, 27)', 'categories': [{'measurements': [{'value': '0.24', 'spread': '0.83', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.86', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: End of Test (n= 25, 28)', 'categories': [{'measurements': [{'value': '2.53', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '2.08', 'groupId': 'OG001'}]}]}, {'title': 'Day 32: 2 minutes after end of test (n= 25, 26)', 'categories': [{'measurements': [{'value': '0.65', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '1.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: Resting (n= 23, 24)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '1.02', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '0.81', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: End of Test (n= 23, 25)', 'categories': [{'measurements': [{'value': '2.46', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Week 8: 2 minutes after end of test (n= 23, 24)', 'categories': [{'measurements': [{'value': '0.32', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '0.58', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Resting (n= 22, 24)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '0.46', 'spread': '0.97', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: End of Test (n= 22, 25)', 'categories': [{'measurements': [{'value': '2.27', 'spread': '1.59', 'groupId': 'OG000'}, {'value': '2.92', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: 2 minutes after end of test (n= 22, 23)', 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: Resting (n= 19, 23)', 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '1.23', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: End of Test (n= 18, 23)', 'categories': [{'measurements': [{'value': '2.50', 'spread': '1.91', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Week 16: 2 minutes after end of test (n= 19, 23)', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '1.25', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: Resting (n= 19, 21)', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.14', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: End of Test (n= 18,22)', 'categories': [{'measurements': [{'value': '2.31', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '3.11', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': 'Week 20: 2 minutes after end of test (n= 18, 20)', 'categories': [{'measurements': [{'value': '0.31', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '1.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: Resting (n= 20, 21)', 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '0.40', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: End of Test (n= 20, 21)', 'categories': [{'measurements': [{'value': '2.58', 'spread': '1.87', 'groupId': 'OG000'}, {'value': '2.93', 'spread': '1.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 24: 2 minutes after end of test (n= 20, 20)', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline breathing ambient air (n=27,28)', 'categories': [{'measurements': [{'value': '61.7', 'spread': '15.6', 'groupId': 'OG000'}, {'value': '59.2', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (1st) (n=20,20)', 'categories': [{'measurements': [{'value': '61.6', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '55.7', 'spread': '12.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (2nd) (n=17,18)', 'categories': [{'measurements': [{'value': '58.1', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 5 mins after NO administration (n=20,14)', 'categories': [{'measurements': [{'value': '60.9', 'spread': '16.2', 'groupId': 'OG000'}, {'value': '56.9', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 15 mins after NO administration(n=19,19)', 'categories': [{'measurements': [{'value': '60.3', 'spread': '16.0', 'groupId': 'OG000'}, {'value': '56.5', 'spread': '10.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 breathing ambient air (n=20,22)', 'categories': [{'measurements': [{'value': '52.5', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '55.5', 'spread': '11.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (1st) (n=10,13)', 'categories': [{'measurements': [{'value': '50.9', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '55.1', 'spread': '13.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (2nd) (n=9,11)', 'categories': [{'measurements': [{'value': '46.2', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '53.9', 'spread': '14.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 5 mins after NO administration (n=10,12)', 'categories': [{'measurements': [{'value': '47.0', 'spread': '15.8', 'groupId': 'OG000'}, {'value': '57.5', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 15 mins after NO administration (n=10,14)', 'categories': [{'measurements': [{'value': '48.1', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '57.2', 'spread': '12.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline breathing ambient air (n=26,28)', 'categories': [{'measurements': [{'value': '9.0', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '2.3', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (1st) (n=20,17)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '7.7', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (2nd) (n=17,16)', 'categories': [{'measurements': [{'value': '9.4', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 5 mins after NO administration (n=19,12)', 'categories': [{'measurements': [{'value': '9.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 15 mins after NO administration(n=18,17)', 'categories': [{'measurements': [{'value': '9.6', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 breathing ambient air (n=19,22)', 'categories': [{'measurements': [{'value': '8.4', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (1st) (n=9,13)', 'categories': [{'measurements': [{'value': '7.9', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '10.2', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (2nd) (n=9,11)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 5 mins after NO administration (n=10,12)', 'categories': [{'measurements': [{'value': '7.1', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 15 mins after NO administration (n=10,14)', 'categories': [{'measurements': [{'value': '6.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Arterial Wedge Pressure (PAWP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline breathing ambient air (n=26,28)', 'categories': [{'measurements': [{'value': '110.3', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '108.2', 'spread': '15.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (1st) (n=20,19)', 'categories': [{'measurements': [{'value': '108.3', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '106.9', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (2nd) (n=17,17)', 'categories': [{'measurements': [{'value': '109.9', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '105.4', 'spread': '18.1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 5 mins after NO administration (n=21,15)', 'categories': [{'measurements': [{'value': '106.0', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '107.1', 'spread': '18.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 15 mins after NO administration(n=19,19)', 'categories': [{'measurements': [{'value': '109.5', 'spread': '20.3', 'groupId': 'OG000'}, {'value': '106.9', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 breathing ambient air (n=20,22)', 'categories': [{'measurements': [{'value': '108.0', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '106.9', 'spread': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (1st) (n=10,13)', 'categories': [{'measurements': [{'value': '103.9', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '102.9', 'spread': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (2nd) (n=9,11)', 'categories': [{'measurements': [{'value': '104.8', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '103.6', 'spread': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 5 mins after NO administration (n=9,12)', 'categories': [{'measurements': [{'value': '103.4', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '104.0', 'spread': '20.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 15 mins after NO administration (n=10,14)', 'categories': [{'measurements': [{'value': '103.8', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '107.3', 'spread': '18.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systolic Arterial Pressure (SAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Heart Rate (HR) at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline breathing ambient air (n=27,28)', 'categories': [{'measurements': [{'value': '77.3', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '84.9', 'spread': '13.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (1st) (n=20,19)', 'categories': [{'measurements': [{'value': '75.9', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '84.4', 'spread': '15.5', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (2nd) (n=17,17)', 'categories': [{'measurements': [{'value': '75.2', 'spread': '13.6', 'groupId': 'OG000'}, {'value': '83.3', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 5 mins after NO administration (n=19,15)', 'categories': [{'measurements': [{'value': '73.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '84.3', 'spread': '13.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 15 mins after NO administration(n=18,19)', 'categories': [{'measurements': [{'value': '76.2', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '85.1', 'spread': '13.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 breathing ambient air (n=20,22)', 'categories': [{'measurements': [{'value': '76.6', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '83.0', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (1st) (n=9,13)', 'categories': [{'measurements': [{'value': '76.3', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '15.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (2nd) (n=8,11)', 'categories': [{'measurements': [{'value': '76.6', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '82.8', 'spread': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 5 mins after NO administration (n=9,12)', 'categories': [{'measurements': [{'value': '75.7', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '79.3', 'spread': '10.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 15 mins after NO administration (n=10,14)', 'categories': [{'measurements': [{'value': '73.2', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '82.9', 'spread': '10.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Heart Rate (HR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Cardiac Output (CO) at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline breathing ambient air (n=27,28)', 'categories': [{'measurements': [{'value': '4.20', 'spread': '1.33', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '1.44', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (1st) (n=19,20)', 'categories': [{'measurements': [{'value': '4.02', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (2nd) (n=17,18)', 'categories': [{'measurements': [{'value': '3.98', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '4.43', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 5 mins after NO administration (n=19,14)', 'categories': [{'measurements': [{'value': '4.20', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '4.71', 'spread': '1.95', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 15 mins after NO administration(n=18,19)', 'categories': [{'measurements': [{'value': '3.87', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '4.47', 'spread': '2.15', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 breathing ambient air (n=20,22)', 'categories': [{'measurements': [{'value': '4.90', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '1.57', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (1st) (n=10,13)', 'categories': [{'measurements': [{'value': '4.80', 'spread': '1.26', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '2.27', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (2nd) (n=9,11)', 'categories': [{'measurements': [{'value': '4.79', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '2.26', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 5 mins after NO administration (n=10,12)', 'categories': [{'measurements': [{'value': '4.63', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '4.65', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 15 mins after NO administration (n=10,14)', 'categories': [{'measurements': [{'value': '4.48', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '4.46', 'spread': '1.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline breathing ambient air (n=27,27)', 'categories': [{'measurements': [{'value': '1124.4', 'spread': '460.0', 'groupId': 'OG000'}, {'value': '1118.3', 'spread': '486.7', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (1st) (n=19,17)', 'categories': [{'measurements': [{'value': '1180.9', 'spread': '520.8', 'groupId': 'OG000'}, {'value': '1067.9', 'spread': '509.1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (2nd) (n=17,16)', 'categories': [{'measurements': [{'value': '1064.6', 'spread': '458.9', 'groupId': 'OG000'}, {'value': '982.8', 'spread': '483.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 5 mins after NO administration (n=19,11)', 'categories': [{'measurements': [{'value': '1131.5', 'spread': '491.2', 'groupId': 'OG000'}, {'value': '1160.4', 'spread': '510.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 15 mins after NO administration(n=18,16)', 'categories': [{'measurements': [{'value': '1181.9', 'spread': '498.7', 'groupId': 'OG000'}, {'value': '1132.9', 'spread': '461.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 breathing ambient air (n=19,21)', 'categories': [{'measurements': [{'value': '729.9', 'spread': '230.1', 'groupId': 'OG000'}, {'value': '1017.0', 'spread': '369.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (1st) (n=9,14)', 'categories': [{'measurements': [{'value': '706.9', 'spread': '285.5', 'groupId': 'OG000'}, {'value': '1000.6', 'spread': '501.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (2nd) (n=9,11)', 'categories': [{'measurements': [{'value': '687.4', 'spread': '276.3', 'groupId': 'OG000'}, {'value': '1033.6', 'spread': '546.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 5 mins after NO administration (n=10,12)', 'categories': [{'measurements': [{'value': '717.2', 'spread': '271.6', 'groupId': 'OG000'}, {'value': '987.8', 'spread': '370.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 15 mins after NO administration (n=10,14)', 'categories': [{'measurements': [{'value': '776.1', 'spread': '286.8', 'groupId': 'OG000'}, {'value': '1042.5', 'spread': '388.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. PVR calculated according to the equation:PVR = (PAP - PCWP)/CO', 'unitOfMeasure': 'dyn*s/cm^5', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline breathing ambient air (n=26,26)', 'categories': [{'measurements': [{'value': '1674.4', 'spread': '761.2', 'groupId': 'OG000'}, {'value': '1764.8', 'spread': '481.9', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (1st) (n=18,15)', 'categories': [{'measurements': [{'value': '1778.2', 'spread': '709.5', 'groupId': 'OG000'}, {'value': '1769.7', 'spread': '457.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline every 2 mins breathing NO (2nd) (n=16,14)', 'categories': [{'measurements': [{'value': '1807.3', 'spread': '615.1', 'groupId': 'OG000'}, {'value': '1664.7', 'spread': '472.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 5 mins after NO administration (n=18,11)', 'categories': [{'measurements': [{'value': '1609.2', 'spread': '593.4', 'groupId': 'OG000'}, {'value': '1666.6', 'spread': '488.6', 'groupId': 'OG001'}]}]}, {'title': 'Baseline 15 mins after NO administration(n=17,15)', 'categories': [{'measurements': [{'value': '1976.3', 'spread': '877.5', 'groupId': 'OG000'}, {'value': '1748.4', 'spread': '499.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 breathing ambient air (n=18,21)', 'categories': [{'measurements': [{'value': '1427.2', 'spread': '446.8', 'groupId': 'OG000'}, {'value': '1667.9', 'spread': '357.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (1st) (n=9,13)', 'categories': [{'measurements': [{'value': '1344.2', 'spread': '474.8', 'groupId': 'OG000'}, {'value': '1579.3', 'spread': '386.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 every 2 mins breathing NO (2nd) (n=9,11)', 'categories': [{'measurements': [{'value': '1367.9', 'spread': '601.7', 'groupId': 'OG000'}, {'value': '1592.5', 'spread': '389.0', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 5 mins after NO administration (n=9,12)', 'categories': [{'measurements': [{'value': '1419.7', 'spread': '566.6', 'groupId': 'OG000'}, {'value': '1503.9', 'spread': '305.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 15 mins after NO administration (n=10,14)', 'categories': [{'measurements': [{'value': '1431.7', 'spread': '524.4', 'groupId': 'OG000'}, {'value': '1629.3', 'spread': '355.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. SVR was calculated according to the equation: SVR = (Paorta - Pright atrium)/CO', 'unitOfMeasure': 'dyn*s/cm^5', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Blood Gas Measurement - PaO2 at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline n=22,21', 'categories': [{'measurements': [{'value': '63.36', 'spread': '14.33', 'groupId': 'OG000'}, {'value': '63.75', 'spread': '12.02', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 n=16,17', 'categories': [{'measurements': [{'value': '72.49', 'spread': '14.09', 'groupId': 'OG000'}, {'value': '70.13', 'spread': '16.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaO2 levels at baseline and Study completion Week 24.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Blood Gas Measurement - PaCO2 at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline n=23,21', 'categories': [{'measurements': [{'value': '32.70', 'spread': '4.40', 'groupId': 'OG000'}, {'value': '30.02', 'spread': '4.76', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 n=16,17', 'categories': [{'measurements': [{'value': '33.36', 'spread': '5.11', 'groupId': 'OG000'}, {'value': '30.23', 'spread': '3.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaCO2 levels at baseline and Study completion Week 24.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Blood Gas Measurement - PvO2 at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline n=14,14', 'categories': [{'measurements': [{'value': '33.16', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '34.70', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 n=11,11', 'categories': [{'measurements': [{'value': '35.56', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '32.65', 'spread': '4.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PvO2 levels at baseline and Study completion Week 24.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline n=19,16', 'categories': [{'measurements': [{'value': '87.99', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '91.81', 'spread': '4.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 n=14,15', 'categories': [{'measurements': [{'value': '92.89', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '91.78', 'spread': '3.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Arterial Saturation levels at baseline and Study completion Week 24.', 'unitOfMeasure': 'percentage of saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Blood Gas Measurement - Venous Saturation at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline n=17,14', 'categories': [{'measurements': [{'value': '57.96', 'spread': '10.48', 'groupId': 'OG000'}, {'value': '60.84', 'spread': '6.61', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 n=13,13', 'categories': [{'measurements': [{'value': '65.11', 'spread': '6.91', 'groupId': 'OG000'}, {'value': '57.00', 'spread': '9.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Venous Saturation levels at baseline and Study completion Week 24.', 'unitOfMeasure': 'percentage of saturation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Blood Gas Measurement - pH at Baseline and Study Completion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'title': 'Baseline n=24,23', 'categories': [{'measurements': [{'value': '7.43', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '7.44', 'spread': '0.05', 'groupId': 'OG001'}]}]}, {'title': 'Week 24 n=17,17', 'categories': [{'measurements': [{'value': '7.44', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '7.46', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including pH levels at baseline and Study completion Week 24. The pH scale measures how acidic or basic a substance is. It ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic.', 'unitOfMeasure': 'pH scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention to treat population (ITT) will include all patients who received at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'FG002', 'title': 'All Patients', 'description': 'Open label extension'}], 'periods': [{'title': 'Core Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawn Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open Label Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Arm in the Core study not extension', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Arm in the Core study not extension', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Arm in the Core study not extension', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Arm in the Core study not extension', 'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Abnormal laboratory values', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'unsatisfactory therapeutic effects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adminiatrative problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Of the 42 participants that completed the Core Study only 22 Participants continued into the Open Label Extension. Not all participants were required to continue into the extension from the core.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'STI571', 'description': 'STI571'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '44.2', 'spread': '15.7', 'groupId': 'BG001'}, {'value': '44.3', 'spread': '15.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2007-05-22', 'resultsFirstSubmitDate': '2015-01-26', 'studyFirstSubmitQcDate': '2007-05-22', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-03-10', 'studyFirstPostDateStruct': {'date': '2007-05-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Core', 'timeFrame': '6 months', 'description': 'In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.'}, {'measure': 'Number of Patients With Adverse Events (AEs), Serious Adverse Events (SAEs) and Death During the Extension', 'timeFrame': '72 months', 'description': 'In this analysis patients with all (serious and non -serious) adverse events, and death were reported. See Safety Section.'}, {'measure': 'Change From Baseline of Six Minute Walk Test - Total Distance Walked at Different Time Periods', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Distance \\<500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance \\>800 meters (with no rests) suggests mild or no limitation.'}, {'measure': 'Change From Baseline of Six Minute Walk Test - Number of Stops at Different Time Periods', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Number of stops were recorded for each patient.'}, {'measure': 'Change From Baseline of Six Minute Walk Test - Total Duration of Stops at Different Time Periods', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'The Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. If the patient stopped the duration of each stop was recorded.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Pulmonary Hypertension (PAH) Assessd by World Health Organization (WHO) Classification on Physical Activity', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion', 'description': 'PAH assessed according to the WHO classification: Class I Patients with PAH but without resulting limitation of physical activity. Ordinary physical activity does not cause undue dyspnea or fatigue, chest pain or near syncope. Class II Patients with PAH resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope. Class III Patients with PAH resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes undue dyspnea or fatigue, chest pain or near syncope. Class IV Patients with PAH with inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.'}, {'measure': 'Borg Score-Oxygen Saturation(SaO2) During the Six Minutes Walk Test at Different Time Periods', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. The test was terminated if the patient became too distressed or if their SaO2% fell below 60%.'}, {'measure': 'Borg Score-Systolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Systolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test'}, {'measure': 'Borg Score-Diastolic Blood Pressure During the Six Minutes Walk Test at Different Time Periods', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Diastolic blood pressure (mmHg) were recorded before the test at resting, at the end of the test and two minutes after the end of the test'}, {'measure': 'Borg Score-Heart Rate (HR) During the Six Minutes Walk Test at Different Time Periods', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Heart Rate (bpm) were recorded before the test at resting, at the end of the test and two minutes after the end of the test'}, {'measure': 'Borg Score During the Six Minutes Walk Test at Different Time Periods', 'timeFrame': 'Baseline, Day 32, Week 8, Week 12, Week 16, Week 20 and Study completion (Week 24)', 'description': 'Borg Score during Six Minute Walk test was carried out along a course, such as a hospital corridor, measuring at least 20 meters delineated by markers. During the walk the patient was connected to a portable pulse oximeter via a finger probe. Patients were instructed to walk at a comfortable speed as far as they could manage in six minutes, resting whenever they needed to. Borg Score of Breathlessness was recorded using the following score of 0 to 10, how breathless do you feel? 0 is nothing at all and 10 is maximal breathlessness'}, {'measure': 'Mean Pulmonary Artery Pressure (PAP) at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including right Pulmonary Arterial Pressure (PAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.'}, {'measure': 'Mean Pulmonary Artery Wedge Pressure (PAWP) at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Arterial Wedge Pressure (PAWP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.'}, {'measure': 'Mean Systolic Arterial Pressure (SAP) at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systolic Arterial Pressure (SAP). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.'}, {'measure': 'Mean Heart Rate (HR) at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Heart Rate (HR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.'}, {'measure': 'Mean Cardiac Output (CO) at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Cardiac Output (CO). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration.'}, {'measure': 'Mean Pulmonary Vascular Resistance (PVR) at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. PVR calculated according to the equation:PVR = (PAP - PCWP)/CO'}, {'measure': 'Mean Systemic Vascular Resistance (SVR) at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess several prognostic hemodynamic variables in pulmonary hypertension, including Systemic Vascular Resistance (SVR). Were assessed when the patient was in a stable hemodynamic rest state (as demonstrated by three consecutive Mean PAP and CO measurements within 10% of each other). PAP was assessed when the patient was breathing ambient air, every 2 minutes whilst breathing Nitric Oxide(NO) (1st and 2nd), 5 min after the end of NO administration, and 15 mins after the end of NO administration. SVR was calculated according to the equation: SVR = (Paorta - Pright atrium)/CO'}, {'measure': 'Blood Gas Measurement - PaO2 at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaO2 levels at baseline and Study completion Week 24.'}, {'measure': 'Blood Gas Measurement - PaCO2 at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PaCO2 levels at baseline and Study completion Week 24.'}, {'measure': 'Blood Gas Measurement - PvO2 at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including PvO2 levels at baseline and Study completion Week 24.'}, {'measure': 'Blood Gas Measurement - Arterial Saturation at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Arterial Saturation levels at baseline and Study completion Week 24.'}, {'measure': 'Blood Gas Measurement - Venous Saturation at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including Venous Saturation levels at baseline and Study completion Week 24.'}, {'measure': 'Blood Gas Measurement - pH at Baseline and Study Completion', 'timeFrame': 'Baseline, and Study completion (Week 24)', 'description': 'The right heart catheter assessment was performed to assess Blood Gas Measurements in pulmonary hypertension, including pH levels at baseline and Study completion Week 24. The pH scale measures how acidic or basic a substance is. It ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary Arterial Hypertension, tyrosine kinase inhibitor, STI571'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'references': [{'pmid': '20581169', 'type': 'DERIVED', 'citation': 'Ghofrani HA, Morrell NW, Hoeper MM, Olschewski H, Peacock AJ, Barst RJ, Shapiro S, Golpon H, Toshner M, Grimminger F, Pascoe S. Imatinib in pulmonary arterial hypertension patients with inadequate response to established therapy. Am J Respir Crit Care Med. 2010 Nov 1;182(9):1171-7. doi: 10.1164/rccm.201001-0123OC. Epub 2010 Jun 25.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety, tolerability, and efficacy of imatinib mesylate in patients with pulmonary arterial hypertension'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of PAH of either primary (idiopathic), familial or secondary to systemic sclerosis (excluding those with marked pulmonary fibrosis) according to World Conference on Pulmonary Hypertension classification (Venice, 2003).\n* Symptoms with a WHO class of II-IV\n\nExclusion Criteria:\n\n* Use of unspecific phosphodiesterase inhibitors (for example, pentoxyfillin, enoximon, milrinone or pimobendan) during the study\n* Chronic inhaled nitric oxide therapy from start to study completion\n* Treatment with catecholamines (for example, adrenalin, noradrenalin, dopamine),\n* Pre-existing lung diseases, including parasitic diseases affecting lungs, asthma, congenital abnormalities of the lungs, chest, and diaphragm.\n* Pulmonary artery or valve stenosis; pulmonary venous hypertension; chronic thromboembolic pulmonary hypertension\n* Acute heart failure or chronic left sided heart failure; congenital or acquired valvular or myocardial disease\n* Severe (systemic) arterial hypertension (\\> 200 mmHg (systolic) or \\> 120 mmHg (diastolic)) Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00477269', 'briefTitle': 'Safety and Efficacy of Imatinib Mesylate in Patients With Pulmonary Arterial Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of the Six Months Treatment With the Tyrosine Kinase Inhibitor STI571 for the Treatment of Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': 'CSTI571E2203'}, 'secondaryIdInfos': [{'id': '2005-005569-12'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STI571', 'description': 'STI571', 'interventionNames': ['Drug: Imatinib mesylate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'All Patients', 'description': 'Open label extension', 'interventionNames': ['Drug: Imatinib mesylate']}], 'interventions': [{'name': 'Imatinib mesylate', 'type': 'DRUG', 'otherNames': ['Imatinib, Glivec, Gleevec, STI571, QTI571'], 'armGroupLabels': ['All Patients', 'STI571']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90073', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '07112', 'city': 'Newark', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis investigative site', 'geoPoint': {'lat': 40.73566, 'lon': -74.17237}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'A-8036', 'city': 'Graz', 'state': 'Austria', 'country': 'Austria', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'city': 'Graz', 'country': 'Austria', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Germany', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '35385', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Giessen', 'country': 'Germany', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'city': 'Hanover', 'country': 'Germany', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'CB23 3RE', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'G11 6NT', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'city': 'Papworth Everard', 'country': 'United Kingdom', 'facility': 'Novartis Investigative site', 'geoPoint': {'lat': 52.24893, 'lon': -0.11827}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}, {'name': 'Novartis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigative site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}