Ignite Creation Date:
2025-12-24 @ 2:27 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00303459
Status:
COMPLETED
Last Update Posted:
2025-02-04
First Post:
2006-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Czechia', 'Denmark', 'Germany', 'Greece', 'Portugal', 'Saudi Arabia', 'Slovakia', 'Spain', 'Sweden', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077300', 'term': 'Bosentan'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonathon.tolson@actelion.com', 'phone': '+41 61 565 56 04', 'title': 'Jonathan Tolson', 'organization': 'Actelion Pharmaceuticals Ltd'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to End of Study and up to 1 day after discontinuation of study treatment, approximately 86 weeks', 'description': 'All treated patients. Treatment emergent adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.', 'otherNumAtRisk': 159, 'otherNumAffected': 135, 'seriousNumAtRisk': 159, 'seriousNumAffected': 73}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.', 'otherNumAtRisk': 174, 'otherNumAffected': 147, 'seriousNumAtRisk': 174, 'seriousNumAffected': 102}], 'otherEvents': [{'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 24}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PULMONARY ARTERIAL HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 35}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'LIVER FUNCTION TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RASH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}], 'seriousEvents': [{'term': 'PULMONARY ARTERIAL HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 28}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DYSPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CHRONIC RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HAEMOPTYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'EPISTAXIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PLEURISY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ACUTE PULMONARY OEDEMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BRONCHIAL HYPERREACTIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'OBLITERATIVE BRONCHIOLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ATELECTASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BRONCHIAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ORTHOPNOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RESPIRATORY DISTRESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'GASTROENTERITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CLOSTRIDIUM DIFFICILE COLITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DIVERTICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SEPTIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Infections and 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'FLUID OVERLOAD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FLUID RETENTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HYPERVOLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HUMERUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HIP FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'LACERATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RIB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FOOT FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'POST PROCEDURAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RENAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'TRANSFUSION-RELATED ACUTE LUNG INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FEMORAL NECK FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FRACTURED SACRUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'INCISIONAL HERNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'LOWER LIMB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PELVIC FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SUBDURAL HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'TOXICITY TO VARIOUS AGENTS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'LIVER FUNCTION TEST ABNORMAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ALANINE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ASPARTATE AMINOTRANSFERASE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ELECTROCARDIOGRAM QT PROLONGED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HEPATIC ENZYME INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'VASCULAR RESISTANCE PULMONARY INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BLOOD BILIRUBIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'WEIGHT DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ANAEMIA HAEMOLYTIC AUTOIMMUNE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SPLENOMEGALY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HYPERSPLENISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'THROMBOCYTOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'THROMBOTIC THROMBOCYTOPENIC PURPURA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'TRANSIENT ISCHAEMIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'NEUROPATHY PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SCIATICA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HYPOAESTHESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BRAIN STEM STROKE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HEMIPARESIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'LUMBAR RADICULOPATHY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'MYASTHENIA GRAVIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PRESYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CORONARY ARTERY BYPASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DIURETIC THERAPY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FINGER AMPUTATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'INCISIONAL HERNIA REPAIR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'KNEE ARTHROPLASTY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CHEMOTHERAPY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RADIOTHERAPY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SKIN CYST EXCISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SKIN NEOPLASM EXCISION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'THYMECTOMY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BRONCHIOLOALVEOLAR CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DIFFUSE LARGE B-CELL LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'UTERINE LEIOMYOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ACOUSTIC NEUROMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BRONCHIAL CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CERVIX CARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'INFLAMMATORY CARCINOMA OF THE BREAST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'MALIGNANT MELANOMA IN SITU', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'MENINGIOMA BENIGN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'METASTATIC MALIGNANT MELANOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RECTAL CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BIPOLAR I DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'MENTAL STATUS CHANGES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'MENORRHAGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'UTERINE HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DYSMENORRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'OVARIAN MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'UTERINE PROLAPSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'VAGINAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'EXTREMITY NECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'FEMORAL ARTERY OCCLUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HAEMATOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PERIPHERAL ARTERIAL OCCLUSIVE DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SHOCK HAEMORRHAGIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RETINAL DETACHMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'EYE SWELLING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HEPATIC CIRRHOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BILIARY DYSKINESIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CHOLECYSTITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CHOLESTASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PORTAL HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'INTERVERTEBRAL DISC PROTRUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'COLLAGEN DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'CREST SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': "DUPUYTREN'S CONTRACTURE", 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HAEMARTHROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'OSTEONECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'ROTATOR CUFF SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SYSTEMIC LUPUS ERYTHEMATOSUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'BLADDER NECK OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'HAEMATURIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'NEPHROLITHIASIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RENAL FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RENAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'RENAL TUBULAR NECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SKIN ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'URTICARIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'SUDDEN HEARING LOSS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}, {'term': 'PREGNANCY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 174, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Confirmed Morbidity/Mortality Event up to the End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Kaplan-Meier estimate at Month 4', 'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 8', 'categories': [{'measurements': [{'value': '90.5', 'groupId': 'OG000'}, {'value': '83.0', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 12', 'categories': [{'measurements': [{'value': '82.7', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 16', 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000'}, {'value': '71.0', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 20', 'categories': [{'measurements': [{'value': '71.8', 'groupId': 'OG000'}, {'value': '66.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 24', 'categories': [{'measurements': [{'value': '66.6', 'groupId': 'OG000'}, {'value': '61.5', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 28', 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000'}, {'value': '55.0', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 32', 'categories': [{'measurements': [{'value': '62.4', 'groupId': 'OG000'}, {'value': '52.7', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 34', 'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 40', 'categories': [{'measurements': [{'value': '56.4', 'groupId': 'OG000'}, {'value': '48.0', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 44', 'categories': [{'measurements': [{'value': '50.6', 'groupId': 'OG000'}, {'value': '46.2', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 48', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000'}, {'value': '45.2', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 52', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}, {'value': '45.2', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 56', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}, {'value': '42.6', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 60', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}, {'value': '39.7', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 64', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}, {'value': '39.7', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 68', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '39.7', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 72', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '39.7', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 76', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 80', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 84', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at End of Study', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2508', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.31', 'paramValue': '0.831', 'ciLowerLimit': '0.582', 'ciUpperLimit': '1.187', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to end of study, approximately 86 months', 'description': 'Kaplan-Meier estimate of percentage of participants without a morbidity/mortality event. A morbidity/mortality event is defined as the occurrence of a) death, b) hospitalization for worsening or complication of PAH or intravenous prostanoid initiation, c) atrial septostomy, d) lung transplantation, or e) worsening PAH, defined as "moderately" or "markedly" worsened PAH symptoms using a patient global self-assessment (PGSA) scale AND initiation of inhaled or subcutaneous prostanoids or the disease progression package (open-label bosentan). If a patient replied "no change" or "mildly worse" on the PGSA, a decrease in 6MWT of 20% versus last visit or 30% versus baseline is also required to confirm the event.', 'unitOfMeasure': 'percentage of participants-Kaplan Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set'}, {'type': 'SECONDARY', 'title': 'Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Kaplan-Meier estimate at Month 4', 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000'}, {'value': '95.3', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 8', 'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000'}, {'value': '91.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 12', 'categories': [{'measurements': [{'value': '89.6', 'groupId': 'OG000'}, {'value': '88.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 16', 'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000'}, {'value': '86.9', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 20', 'categories': [{'measurements': [{'value': '82.3', 'groupId': 'OG000'}, {'value': '83.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 24', 'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000'}, {'value': '79.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 28', 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000'}, {'value': '74.7', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 32', 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000'}, {'value': '73.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 36', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 40', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}, {'value': '61.9', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 44', 'categories': [{'measurements': [{'value': '64.2', 'groupId': 'OG000'}, {'value': '60.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 48', 'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000'}, {'value': '58.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 52', 'categories': [{'measurements': [{'value': '57.4', 'groupId': 'OG000'}, {'value': '56.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 56', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '52.7', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 60', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '51.3', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 64', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '51.3', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 68', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '49.2', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 72', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '49.2', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 76', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 80', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 84', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at End of Study', 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000'}, {'value': '45.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8385', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.963', 'ciLowerLimit': '0.673', 'ciUpperLimit': '1.380', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to end of study, approximately 86 months', 'description': 'Kaplan-Meier estimate of percentage of participants without an event of death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation. Time to first confirmed death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation from baseline to end of study was confirmed by an independent Clinical Endpoint Committee.', 'unitOfMeasure': 'percentage of participants-Kaplan Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '363', 'spread': '78.5', 'groupId': 'OG000'}, {'value': '358', 'spread': '73.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '370', 'spread': '98.3', 'groupId': 'OG000'}, {'value': '343', 'spread': '107.3', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '7.2', 'spread': '66.01', 'groupId': 'OG000'}, {'value': '-14.6', 'spread': '80.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0106', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.8', 'ciLowerLimit': '5.9', 'ciUpperLimit': '37.8', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to week 16', 'description': 'The 6MWT is a non-encouraged test, which measures the distance covered over a 6 minute walk; the patient is instructed to walk as far as possible in a 30 m long flat corridor, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Areas were to be well ventilated with air temperature controlled between 20 °C and 23 °C (68 °F to 76 °F). The test was to be administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6 minute period.', 'unitOfMeasure': 'm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '1.0000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Relative risk of improvement', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.61', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline to Week 16', 'description': 'Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set'}, {'type': 'SECONDARY', 'title': 'Time to Death of All Causes From Baseline to End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Kaplan-Meier estimate at Month 4', 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000'}, {'value': '98.2', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 8', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000'}, {'value': '95.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 12', 'categories': [{'measurements': [{'value': '96.5', 'groupId': 'OG000'}, {'value': '94.0', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 16', 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000'}, {'value': '92.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 20', 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000'}, {'value': '89.5', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 24', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 28', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}, {'value': '85.9', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 32', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}, {'value': '84.3', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 36', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}, {'value': '78.5', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 40', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000'}, {'value': '76.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 44', 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000'}, {'value': '74.9', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 48', 'categories': [{'measurements': [{'value': '77.7', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 52', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '70.5', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 56', 'categories': [{'measurements': [{'value': '70.1', 'groupId': 'OG000'}, {'value': '66.4', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 60', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '64.9', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 64', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '64.9', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 68', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '64.9', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 72', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '64.9', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 76', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '60.3', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 80', 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}, {'value': '60.3', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at Month 84', 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}, {'value': '60.3', 'groupId': 'OG001'}]}]}, {'title': 'Kaplan-Meier estimate at End of Study', 'categories': [{'measurements': [{'value': '58.1', 'groupId': 'OG000'}, {'value': '60.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4974', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.855', 'ciLowerLimit': '0.544', 'ciUpperLimit': '1.344', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to End of Study, approximately 86 months', 'description': 'Kaplan-Meier estimate of percentage of participants without a mortality event.Time to death due to any cause.', 'unitOfMeasure': 'percentage of participants-Kaplan Meier', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set'}, {'type': 'SECONDARY', 'title': 'Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet, b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Month 1 to Baseline', 'categories': [{'measurements': [{'value': '87.46', 'groupId': 'OG000', 'lowerLimit': '77.12', 'upperLimit': '99.18'}, {'value': '110.02', 'groupId': 'OG001', 'lowerLimit': '97.56', 'upperLimit': '124.06'}]}]}, {'title': 'Month 4 to Baseline', 'categories': [{'measurements': [{'value': '92.65', 'groupId': 'OG000', 'lowerLimit': '81.20', 'upperLimit': '105.72'}, {'value': '113.20', 'groupId': 'OG001', 'lowerLimit': '99.61', 'upperLimit': '128.65'}]}]}, {'title': 'Month 8 to Baseline', 'categories': [{'measurements': [{'value': '85.21', 'groupId': 'OG000', 'lowerLimit': '72.58', 'upperLimit': '100.05'}, {'value': '122.87', 'groupId': 'OG001', 'lowerLimit': '104.82', 'upperLimit': '144.02'}]}]}, {'title': 'Month 12 to Baseline', 'categories': [{'measurements': [{'value': '84.48', 'groupId': 'OG000', 'lowerLimit': '71.48', 'upperLimit': '99.83'}, {'value': '132.11', 'groupId': 'OG001', 'lowerLimit': '111.95', 'upperLimit': '155.89'}]}]}, {'title': 'Month 16 to Baseline', 'categories': [{'measurements': [{'value': '92.69', 'groupId': 'OG000', 'lowerLimit': '75.75', 'upperLimit': '113.42'}, {'value': '129.92', 'groupId': 'OG001', 'lowerLimit': '106.69', 'upperLimit': '158.20'}]}]}, {'title': 'Month 20 to Baseline', 'categories': [{'measurements': [{'value': '98.36', 'groupId': 'OG000', 'lowerLimit': '79.46', 'upperLimit': '121.75'}, {'value': '143.17', 'groupId': 'OG001', 'lowerLimit': '115.86', 'upperLimit': '176.91'}]}]}, {'title': 'Treatment effect over 20 months', 'categories': [{'measurements': [{'value': '92.54', 'groupId': 'OG000', 'lowerLimit': '82.72', 'upperLimit': '103.52'}, {'value': '121.00', 'groupId': 'OG001', 'lowerLimit': '108.42', 'upperLimit': '135.05'}]}]}], 'analyses': [{'pValue': '0.0003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage change over placebo', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.52', 'ciLowerLimit': '-33.69', 'ciUpperLimit': '-11.79', 'statisticalMethod': 'Repeated measures analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline to Month 20', 'description': 'Blood sampling for the measurement of NT-pro-BNP was performed and the plasma concentrations of NT-pro-BNP were determined by a certified centralized laboratory.', 'unitOfMeasure': 'Adjusted percentage ratio from baseline', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized patients with a baseline and at least one post-baseline value. Assessments considered are those where at least 60% of the patients have a post-baseline value'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Borg Dyspnea Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '2.18', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '3.4', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '2.24', 'groupId': 'OG001'}]}]}, {'title': 'Change from baseline', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '1.693', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '2.035', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9566', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01', 'ciLowerLimit': '-0.42', 'ciUpperLimit': '0.39', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': "The Borg dyspnea index was evaluated immediately after the 6MWT to obtain a rating of dyspnea at the end of the exercise using a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal').", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.678', 'spread': '0.2172', 'groupId': 'OG000'}, {'value': '0.681', 'spread': '0.2138', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '0.662', 'spread': '0.2807', 'groupId': 'OG000'}, {'value': '0.645', 'spread': '0.3062', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '-0.0161', 'spread': '0.25232', 'groupId': 'OG000'}, {'value': '-0.0361', 'spread': '0.26671', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5571', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.020', 'ciLowerLimit': '-0.036', 'ciUpperLimit': '0.076', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 16', 'description': 'The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS). The descriptive system asks respondents to describe their health status. Health is defined in 5 dimensions: (1) mobility, (2) self care, (3) usual activities, (4) pain or discomfort, and (5) anxiety or depression. Each dimension is divided into 3 levels, indicating (a) no problem, (b) some or moderate problems, or (c) extreme problems. Respondents record their problem(s) in each of the 5 dimensions. Combinations of these levels define a total of 243 health states. A health state defined by the descriptive system of EQ-5D can be described by a 5-digit number with full health is indicated by 11111 and poorest health state by 33333. The EQ-5D calculated score was derived by re-assigning local scores for answers to each question and combining these local scores into a global score with ranges from 0 (worst possible outcome) to 1 (best possible outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '67', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '64', 'spread': '17.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'categories': [{'measurements': [{'value': '69', 'spread': '19.9', 'groupId': 'OG000'}, {'value': '66', 'spread': '19.9', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '18.83', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '17.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4086', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '4.0', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 16', 'description': "The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS) together with brief demographic questions. EQ-5D VAS asks respondents to rate their perception of their overall health on a vertical visual analogue scale with 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set'}, {'type': 'SECONDARY', 'title': 'Patient Global Self Assessment (PGSA) Status at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'classes': [{'title': 'Markedly better', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Moderately better', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Mildly better', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Mildly worse', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Moderately worse', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Markedly worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'The PGSA is a questionnaire that allows the patient to compare his/her PAH status in response to the question "How do you feel about your PAH today compared with your last visit?" asked by the investigator. Patients use a seven-point scale to respond: markedly better, moderately better, mildly better, no change, markedly worse, moderately worse, or mildly worse.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized set, patients who completed the assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet, twice a day (b.i.d.) for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'comment': 'One subject randomized to placebo did not receive study treatment', 'groupId': 'FG001', 'numSubjects': '175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '86'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '83'}, {'groupId': 'FG001', 'numSubjects': '89'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'Withdrawal of consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Decision by the investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lung transplantation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'First subject, first visit was17 May 2006 and last subject, last visit was 05 Dec 2013.', 'preAssignmentDetails': 'There was a screening period of up to 14 days to assess eligibility. A total of 377 patients were screened.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '334', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bosentan', 'description': 'Bosentan\n\nbosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo\n\nplacebo: Matching bosentan placebo/b.i.d.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.9', 'spread': '15.44', 'groupId': 'BG000'}, {'value': '54.7', 'spread': '15.73', 'groupId': 'BG001'}, {'value': '53.9', 'spread': '15.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian/White', 'categories': [{'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Saudi Arabia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2006-03-16', 'resultsFirstSubmitDate': '2015-01-02', 'studyFirstSubmitQcDate': '2006-03-16', 'lastUpdatePostDateStruct': {'date': '2025-02-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-01-22', 'studyFirstPostDateStruct': {'date': '2006-03-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Confirmed Morbidity/Mortality Event up to the End of Study', 'timeFrame': 'From baseline to end of study, approximately 86 months', 'description': 'Kaplan-Meier estimate of percentage of participants without a morbidity/mortality event. A morbidity/mortality event is defined as the occurrence of a) death, b) hospitalization for worsening or complication of PAH or intravenous prostanoid initiation, c) atrial septostomy, d) lung transplantation, or e) worsening PAH, defined as "moderately" or "markedly" worsened PAH symptoms using a patient global self-assessment (PGSA) scale AND initiation of inhaled or subcutaneous prostanoids or the disease progression package (open-label bosentan). If a patient replied "no change" or "mildly worse" on the PGSA, a decrease in 6MWT of 20% versus last visit or 30% versus baseline is also required to confirm the event.'}], 'secondaryOutcomes': [{'measure': 'Time to First Confirmed Death, Hospitalization for Worsening or Complication of PAH or Initiation of Intravenous Prostanoids, Atrial Septostomy, or Lung Transplantation', 'timeFrame': 'Baseline to end of study, approximately 86 months', 'description': 'Kaplan-Meier estimate of percentage of participants without an event of death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation. Time to first confirmed death, hospitalization (for worsening or complication of PAH or initiation of intravenous prostanoids), atrial septostomy or lung transplantation from baseline to end of study was confirmed by an independent Clinical Endpoint Committee.'}, {'measure': 'Change From Baseline to Week 16 in 6 Minute Walk Test (6MWT)', 'timeFrame': 'From baseline to week 16', 'description': 'The 6MWT is a non-encouraged test, which measures the distance covered over a 6 minute walk; the patient is instructed to walk as far as possible in a 30 m long flat corridor, back and forth around two cones, with the permission to slow down, rest, or stop if needed. Areas were to be well ventilated with air temperature controlled between 20 °C and 23 °C (68 °F to 76 °F). The test was to be administered at the same time of day and by the same tester throughout the study. The tester measured the distance walked by non-encouraged patients during the timed 6 minute period.'}, {'measure': 'Number of Participants With Improved, No Change, or Worsened World Health Organisation Functional Class From Baseline to Week 16', 'timeFrame': 'From baseline to Week 16', 'description': 'Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.'}, {'measure': 'Time to Death of All Causes From Baseline to End of Study', 'timeFrame': 'Baseline to End of Study, approximately 86 months', 'description': 'Kaplan-Meier estimate of percentage of participants without a mortality event.Time to death due to any cause.'}, {'measure': 'Adjusted Percentage Ratio From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-pro-BNP)', 'timeFrame': 'Baseline to Month 20', 'description': 'Blood sampling for the measurement of NT-pro-BNP was performed and the plasma concentrations of NT-pro-BNP were determined by a certified centralized laboratory.'}, {'measure': 'Change From Baseline to Week 16 in Borg Dyspnea Index', 'timeFrame': 'Baseline to Week 16', 'description': "The Borg dyspnea index was evaluated immediately after the 6MWT to obtain a rating of dyspnea at the end of the exercise using a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal')."}, {'measure': 'Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Questionnaire Calculated Score', 'timeFrame': 'From baseline to Week 16', 'description': 'The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS). The descriptive system asks respondents to describe their health status. Health is defined in 5 dimensions: (1) mobility, (2) self care, (3) usual activities, (4) pain or discomfort, and (5) anxiety or depression. Each dimension is divided into 3 levels, indicating (a) no problem, (b) some or moderate problems, or (c) extreme problems. Respondents record their problem(s) in each of the 5 dimensions. Combinations of these levels define a total of 243 health states. A health state defined by the descriptive system of EQ-5D can be described by a 5-digit number with full health is indicated by 11111 and poorest health state by 33333. The EQ-5D calculated score was derived by re-assigning local scores for answers to each question and combining these local scores into a global score with ranges from 0 (worst possible outcome) to 1 (best possible outcome).'}, {'measure': 'Change From Baseline to Week 16 in the EuroQol 5 Dimensions (EQ-5D) Visual Analogue Scale Score', 'timeFrame': 'Baseline to Week 16', 'description': "The EQ-5D questionnaire is a patient-reported outcome consisting of a 5 dimensional descriptive system and a visual analog scale (VAS) together with brief demographic questions. EQ-5D VAS asks respondents to rate their perception of their overall health on a vertical visual analogue scale with 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0."}, {'measure': 'Patient Global Self Assessment (PGSA) Status at Week 16', 'timeFrame': 'Week 16', 'description': 'The PGSA is a questionnaire that allows the patient to compare his/her PAH status in response to the question "How do you feel about your PAH today compared with your last visit?" asked by the investigator. Patients use a seven-point scale to respond: markedly better, moderately better, mildly better, no change, markedly worse, moderately worse, or mildly worse.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sildenafil', 'Combination Drug Therapy', 'bosentan', 'Pulmonary Hypertension', 'Pulmonary Arterial Hypertension', 'Multicenter Study', 'Antihypertensive Agents', 'Tracleer', 'endothelin receptor antagonist', 'Randomized Controlled Trial', 'Phosphodiesterase type 5 inhibitor (PDE5i)', 'Outcome Assessment'], 'conditions': ['Pulmonary Arterial Hypertension']}, 'referencesModule': {'references': [{'pmid': '26113687', 'type': 'DERIVED', 'citation': 'McLaughlin V, Channick RN, Ghofrani HA, Lemarie JC, Naeije R, Packer M, Souza R, Tapson VF, Tolson J, Al Hiti H, Meyer G, Hoeper MM. Bosentan added to sildenafil therapy in patients with pulmonary arterial hypertension. Eur Respir J. 2015 Aug;46(2):405-13. doi: 10.1183/13993003.02044-2014. Epub 2015 Jun 25.'}], 'seeAlsoLinks': [{'url': 'http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails', 'label': 'Tracleer for PAH approval page at Drugs@FDA.gov'}]}, 'descriptionModule': {'briefSummary': 'COMPASS-2 is a Phase 4, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first confirmed morbidity/mortality event in patients with symptomatic PAH already receiving sildenafil therapy. Patients must have been receiving doses of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to being randomized.\n\nThe study continued until the predefined target number of morbidity/mortality events was reached.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent prior to initiation of any study-mandated procedure\n2. Males or females \\>=12 years of age (except for countries where this age limit is contrary to specific regulatory requirements).\n\n \\- Women of childbearing potential must have a negative pretreatment pregnancy test and must use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.\n\n ·Reliable methods of contraception are:\n\n O Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.\n\n O Intrauterine devices. O Oral, transdermal, injectable or implantable contraceptives only in combination with a barrier method.\n * Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception.\n * Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.\n\n * Women not of childbearing potential are defined as postmenopausal (i.e., amenorrhea for at least 1 year), or documented surgically or naturally sterile.\n3. Patients with symptomatic PAH\n4. Patients with the following types of PAH belonging to WHO Group I:\n\n * Idiopathic (IPAH)\n * Familial (FPAH)\n * Associated with (APAH):\n\n i. Collagen vascular disease with normal left ventricular function (ejection fraction (EF) \\> 50%) ii. Congenital systemic-to-pulmonary shunts at least 2 years post surgical repair iii. Drugs and toxins\n5. PAH diagnosed by right heart catheter showing:\n\n * Mean pulmonary arterial pressure (mPAP) \\>= 25 mm Hg AND\n * Pulmonary capillary wedge pressure (PCWP) =\\< 15 mm Hg or left ventricular end diastolic pressure (LVEDP) =\\< 15 mmHg If both PCWP and LVEDP are available then the LVEDP value is retained for inclusion.\n6. Treatment with a stable dose of sildenafil equal to or greater than 20 mg t.i.d. for at least 12 weeks prior to randomization (no sildenafil dosage adjustment should occur in this period) 7)150 m =\\< 6-minute walk test (6MWT) =\\< 480 m, documented by 2 tests with second 6MWT within 15% of first 6MWT distance or a third test required\n\nExclusion Criteria :\n\n1. PAH belonging to WHO group II-V\n2. PAH associated with portal hypertension and HIV infection\n3. PAH associated with thyroid disorders, glycogen storage disease, Gaucher disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders and splenectomy\n4. PAH associated with significant venous or capillary involvement (PCWP \\> 15 mmHg): pulmonary veno-occlusive disease and pulmonary capillary hemangiomatosis\n5. Persistent pulmonary hypertension of the newborn\n6. Significant valvular disease with valvular lesions to be excluded by echocardiogram within 2 years prior to randomization (i.e. patients with tricuspid or pulmonary insufficiency secondary to PAH can be included)\n7. Restrictive lung disease: total lung capacity (TLC) \\< 60% of normal predicted value (see Appendix 3)\n8. Obstructive lung disease: forced expiratory volume/forced vital capacity (FEV1/FVC) \\< 0.5\n9. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C\n10. Known HIV infection\n11. Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements or that may interfere with the safety or the evaluation of the study, such as chronic infection, chronic renal failure etc.\n12. Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements\n13. Pregnancy or breast-feeding\n14. Condition that prevents compliance with the protocol or adherence to therapy\n15. Systolic blood pressure \\< 85 mmHg\n16. Body weight \\< 40 kg\n17. Hemoglobin \\<75% of the lower limit of the normal range\n18. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\> 1.5 times the upper limit of normal ranges\n19. Known hypersensitivity or history of drug-related adverse events with bosentan (e.g. increase in liver function test results), or any of the excipients of its formulation\n20. Receipt of an investigational product other than sildenafil within 3 months before start of study treatment\n21. Treatment with endothelin receptor antagonists (ERAs), prostanoids or phosphodiesterase (PDE) 5 inhibitors other than sildenafil within 3 months prior to randomization\n22. Concomitant systemic treatment within 1 week prior to randomization with\n\n * calcineurin inhibitors (e.g., cyclosporine A and tacrolimus), sirolimus and everolimus\n * glibenclamide (glyburide)\n * both cytochrome P2C9 (CYP2C9) and cytochrome P3A4 (CYP3A4) (e.g., fluconazole, amiodarone, voriconazole)\n * combination of drugs that inhibit CYP2C9 and CYP3A4\n23. Treatment with nitrates and alpha-blockers at time of randomization\n24. In the opinion of the investigator - patients in need for treatment with any prostanoid up to Visit 4\n25. Significant left ventricular dysfunction'}, 'identificationModule': {'nctId': 'NCT00303459', 'acronym': 'Compass-2', 'briefTitle': 'Effects of the Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Pulmonary Arterial Hypertension (PAH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Actelion'}, 'officialTitle': 'Effects of Combination of Bosentan and Sildenafil Versus Sildenafil Monotherapy on Morbidity and Mortality in Symptomatic Patients With Pulmonary Arterial Hypertension - A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group, Prospective, Event Driven Phase IV Study', 'orgStudyIdInfo': {'id': 'AC-052-414'}, 'secondaryIdInfos': [{'id': 'COMPASS-2', 'type': 'OTHER', 'domain': 'Actelion Pharmaceuticals Ltd'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Bosentan', 'interventionNames': ['Drug: bosentan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'description': 'Placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'bosentan', 'type': 'DRUG', 'description': 'bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d.', 'armGroupLabels': ['A']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Matching bosentan placebo/b.i.d.', 'armGroupLabels': ['B']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Actelion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}