Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:37 PM
Study NCT ID:
NCT00810693
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2008-12-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland', 'Netherlands', 'Slovakia']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542595', 'term': 'riociguat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'otherDetails': 'The embargo can be up to 6 months (equal to the 180 days), moreover if it is necessary the embargo period can be prolonged to expiry of priority year.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected after signing the informed consent until 2 days after end of study treatment over a period of approximately 30 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks', 'otherNumAtRisk': 254, 'otherNumAffected': 216, 'seriousNumAtRisk': 254, 'seriousNumAffected': 29}, {'id': 'EG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks', 'otherNumAtRisk': 63, 'otherNumAffected': 57, 'seriousNumAtRisk': 63, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks', 'otherNumAtRisk': 126, 'otherNumAffected': 96, 'seriousNumAtRisk': 126, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Activated partial thromboplastin time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Iron deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pharyngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cardiomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 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{'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 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'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 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'MedDRA (15.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Mycoplasma infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Muscle rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Catheterisation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Electrocardiogram ST-T segment abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Metastatic malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Vaginal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Pulmonary arterial hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 254, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 63, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 126, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '29.6', 'spread': '65.8', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '79.3', 'groupId': 'OG001'}, {'value': '-5.6', 'spread': '85.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Prespecified significance level for all significance tests was 5%. Primary analysis due to result of Shapiro-Wilk test.', 'groupDescription': 'Missing values for participants who withdrew/died before 12 weeks were imputed with worst value of 0m in case of death or clinical worsening without termination visit and with last observed value otherwise. Comparison was done using ANCOVA, with baseline 6MWD as a covariate and treatment group, region and treatment naive/add-on therapy as main effects. The primary statistical method was the stratified Wilcoxon test if the Shapiro-Wilk test for normality of residuals was statistically significant', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Test was stratified by region and therapy naive/add-on therapy'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.78', 'ciLowerLimit': '20.06', 'ciUpperLimit': '51.51', 'pValueComment': 'Additional analysis due to result of Shapiro-Wilk test.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Shapiro-Wilk test for normality of ANCOVA residuals.', 'statisticalMethod': 'Shapiro-Wilk', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': "6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.", 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.'}, {'type': 'SECONDARY', 'title': 'Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-223.29', 'spread': '260.09', 'groupId': 'OG000'}, {'value': '-167.79', 'spread': '320.22', 'groupId': 'OG001'}, {'value': '-8.89', 'spread': '316.57', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, TTCW, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.', 'groupDescription': 'Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Test was stratified by region and therapy naive/add-on therapy'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-225.72', 'ciLowerLimit': '-281.37', 'ciUpperLimit': '-170.08', 'pValueComment': 'Additional analysis due to result of Shapiro-Wilk test.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Shapiro-Wilk test for normality of ANCOVA residuals.', 'statisticalMethod': 'Shapiro-Wilk', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80\\*(PAPmean - PCWP)/CO', 'unitOfMeasure': 'dyn*s*cm^-5', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of PVR.'}, {'type': 'SECONDARY', 'title': 'N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-197.89', 'spread': '1721.29', 'groupId': 'OG000'}, {'value': '-471.50', 'spread': '913.02', 'groupId': 'OG001'}, {'value': '232.39', 'spread': '1011.09', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.\n\nPrimary analysis due to result of Shapiro-Wilk test.', 'groupDescription': 'Missing values at week 12 were imputed using the last available post-baseline observation. Same analysis method as for primary efficacy parameter.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Test was stratified by region and therapy naive/add-on therapy'}, {'pValue': '0.0157', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-431.81', 'ciLowerLimit': '-781.52', 'ciUpperLimit': '-82.10', 'pValueComment': 'Additional analysis due to result of Shapiro-Wilk test.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Shapiro-Wilk test for normality of ANCOVA residuals.', 'statisticalMethod': 'Shapiro-Wilk', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Only participants with a baseline and at least one post-baseline measurement were included in the analysis of NT-proBNP.'}, {'type': 'SECONDARY', 'title': 'World Health Organization (WHO) Functional Class - Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'classes': [{'title': '-2', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': '-1', 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000'}, {'value': '23.8', 'groupId': 'OG001'}, {'value': '14.4', 'groupId': 'OG002'}]}]}, {'title': '0', 'categories': [{'measurements': [{'value': '75.6', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}, {'value': '71.2', 'groupId': 'OG002'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}, {'value': '12.0', 'groupId': 'OG002'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0033', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.', 'groupDescription': 'Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of IV in case of clinical worsening without termination visit or measurement at that termination visit and with a worst value of V in case of death and with the last observed value otherwise.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Test was stratified by region and therapy naive/add-on therapy'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and week 12', 'description': 'The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of WHO functional class.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'classes': [{'title': 'Any event', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}, {'value': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Hospitalization due to pulmonary hypertension', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Start of new pulmonary hypertension treatment', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '4.0', 'groupId': 'OG002'}]}]}, {'title': 'Decrease in 6MWT due to pulmonary hypertension', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'Persistant worsening of functional class due to PH', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '2.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0046', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.20', 'ciLowerLimit': '-9.85', 'ciUpperLimit': '-0.55', 'pValueComment': 'Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.', 'estimateComment': 'Based on Mantel-Haenszel estimate stratified by region and therapy naive/add-on therapy.', 'groupDescription': 'The test is for difference of occurence of "Any event".', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Test was stratified by region and therapy naive/add-on therapy'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 12', 'description': 'The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.'}, {'type': 'SECONDARY', 'title': 'Borg CR 10 Scale - Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.44', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-0.33', 'spread': '1.47', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '2.05', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0022', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH.', 'groupDescription': 'Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 10 in case of death or clinical worsening without termination visit and with the last observed value otherwise.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Test was stratified by region and therapy naive/add-on therapy'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant\'s exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered.'}, {'type': 'SECONDARY', 'title': 'EQ-5D Utility Score - Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '124', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0329', 'spread': '0.2350', 'groupId': 'OG000'}, {'value': '0.0782', 'spread': '0.3111', 'groupId': 'OG001'}, {'value': '-0.0317', 'spread': '0.3044', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0663', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO functional class, Time to clinical worsening, Borg scale, EQ5D, LPH. Primary analysis due to result of Shapiro-Wilk test.', 'groupDescription': 'Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of -0.594 in case of death or clinical worsening without termination visit and with the last observed value otherwise.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Test was stratified by region and therapy naive/add-on therapy.'}, {'pValue': '0.0197', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '0.01', 'ciUpperLimit': '0.11', 'pValueComment': 'Additional analysis due to result of Shapiro-Wilk test.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Shapiro-Wilk test for normality of ANCOVA residuals.', 'statisticalMethod': 'Shapiro-Wilk', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': 'EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the EQ5D utility score.'}, {'type': 'SECONDARY', 'title': 'Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.99', 'spread': '17.76', 'groupId': 'OG000'}, {'value': '-10.21', 'spread': '21.27', 'groupId': 'OG001'}, {'value': '0.36', 'spread': '18.15', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0019', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Hierarchical testing for secondary efficacy parameters in the order: PVR, NT-proBNP, WHO FC, TTCW, Borg scale, EQ5D, LPH.\n\nPrimary analysis due to result of Shapiro-Wilk test. Nominally significant only due to hierarchical testing.', 'groupDescription': 'Missing values at baseline were imputed using last available observation prior to start of study treatment. Missing values for participants who withdrew or died before 12 weeks were imputed with a worst value of 105 in case of death or clinical worsening without termination visit and with the last observed value otherwise.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Test was stratified by region and therapy naive/add-on therapy.'}, {'pValue': '0.0009', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.17', 'ciLowerLimit': '-9.79', 'ciUpperLimit': '-2.54', 'pValueComment': 'Additional analysis due to result of Shapiro-Wilk test.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0001', 'groupIds': ['OG000', 'OG002'], 'groupDescription': 'Shapiro-Wilk test for normality of ANCOVA residuals.', 'statisticalMethod': 'Shapiro-Wilk', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and week 12', 'description': "The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst).", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) - a randomized participant was valid for ITT analyses if at least one dose of study medication was administered. Participants with a missing baseline were excluded from the analysis of the LPH questionnaire.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'FG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'comment': '1 randomized but not treated', 'groupId': 'FG001', 'numSubjects': '64'}, {'comment': '1 randomized but not treated', 'groupId': 'FG002', 'numSubjects': '127'}]}, {'type': 'Participants Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '254'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '126'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Follow-up Period (FUP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Started FUP only if prematurely withdrawn from trt period or if not entering LTE study.', 'groupId': 'FG000', 'numSubjects': '23'}, {'comment': 'Started FUP only if prematurely withdrawn from trt period or if not entering LTE study.', 'groupId': 'FG001', 'numSubjects': '7'}, {'comment': 'Started FUP only if prematurely withdrawn from trt period or if not entering LTE study.', 'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Only participants with symptomatic Pulmonary arterial hypertension (PAH) could participate in this study. Both treatment-naïve participants and participants pre-treated with an endothelin receptor antagonist or a non-intravenous prostacyclin analogue could be included.', 'preAssignmentDetails': '586 participants were enrolled in 124 study centers in 30 countries worldwide. 141 of the 586 enrolled participants were not randomized (adverse event \\[4\\], protocol violation \\[129\\], withdrawal by subject \\[8\\]). 445 of the 586 participants were randomized. 443 of the 445 randomized participants received study medication.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '254', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '443', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'BG001', 'title': 'Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT', 'description': 'Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '16.6', 'groupId': 'BG000'}, {'value': '48.8', 'spread': '16.1', 'groupId': 'BG001'}, {'value': '50.7', 'spread': '16.5', 'groupId': 'BG002'}, {'value': '50.6', 'spread': '16.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '350', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '139', 'groupId': 'BG003'}]}]}, {'title': 'Mixed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Not reported', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Prior PH therapy', 'classes': [{'title': 'Therapy-Naive', 'categories': [{'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '221', 'groupId': 'BG003'}]}]}, {'title': 'Pre-Treated', 'categories': [{'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '222', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'pre-treated with endothelin receptor antagonist', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '194', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects pre-treated with an endothelin receptor antagonist.', 'unitOfMeasure': 'Participants'}, {'title': 'pre-treated with prostacyclin analogue', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '412', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Subjects pre-treated with a prostacyclin analogue.', 'unitOfMeasure': 'Participants'}, {'title': 'PAH subtype', 'classes': [{'title': 'Idiopathic PAH', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '272', 'groupId': 'BG003'}]}]}, {'title': 'Familial PAH', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Connective tissue disease assoc. PAH', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}]}, {'title': 'Congenital heart disease (operated) assoc. PAH', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}, {'title': 'Portal Pulmonary hypertension', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Anorexigen or Amphtamin assoc: PAH', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Subtypes acc. to the Venice Clinical Classification of PH, Group 1 (idiopathic PAH, familial PAH, associated PAH due to \\[1\\] connective tissue disease, \\[2\\] congenital heart disease, \\[3\\] portal hypertension with liver cirrhosis, or \\[4\\] anorexigen or amphetamine use)', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.91', 'spread': '5.48', 'groupId': 'BG000'}, {'value': '26.85', 'spread': '5.35', 'groupId': 'BG001'}, {'value': '26.26', 'spread': '5.92', 'groupId': 'BG002'}, {'value': '26.14', 'spread': '5.59', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline 6MWD', 'classes': [{'categories': [{'measurements': [{'value': '361.4', 'spread': '67.7', 'groupId': 'BG000'}, {'value': '363.2', 'spread': '66.6', 'groupId': 'BG001'}, {'value': '367.8', 'spread': '74.6', 'groupId': 'BG002'}, {'value': '363.5', 'spread': '69.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity.", 'unitOfMeasure': 'meters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'WHO (World Health Organization) functional class', 'classes': [{'title': 'I', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'II', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}]}, {'title': 'III', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '237', 'groupId': 'BG003'}]}]}, {'title': 'IV', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.', 'unitOfMeasure': 'Participants'}, {'title': 'Pulmonary vascular resistance', 'classes': [{'categories': [{'measurements': [{'value': '790.96', 'spread': '452.60', 'groupId': 'BG000'}, {'value': '847.81', 'spread': '548.17', 'groupId': 'BG001'}, {'value': '834.06', 'spread': '476.71', 'groupId': 'BG002'}, {'value': '810.89', 'spread': '473.45', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80\\*(PAPmean - PCWP)/CO', 'unitOfMeasure': 'dn*s*cm^-5', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 445}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2012-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2008-12-17', 'resultsFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2008-12-17', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-24', 'studyFirstPostDateStruct': {'date': '2008-12-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 Minutes Walking Distance (6MWD) - Change From Baseline to Week 12', 'timeFrame': 'Baseline and week 12', 'description': "6-minute walking distance (6MWD) is a measure for the objective evaluation of a patient's functional exercise capacity."}], 'secondaryOutcomes': [{'measure': 'Pulmonary Vascular Resistance (PVR) - Change From Baseline to Week 12', 'timeFrame': 'Baseline and week 12', 'description': 'The pulmonary vascular resistance (PVR) is a calculated hemodynamic parameter. PVR is derived from the directly measured parameters mean pulmonary arterial pressure (PAPmean) and pulmonary capillary wedge pressure (PCWP), divided by the cardiac output (CO). PVR and PAPmean are acquired during a right heart catheterization. CO is a calculated hemodynamic parameter, too. Formula: PVR = 80\\*(PAPmean - PCWP)/CO'}, {'measure': 'N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP) - Change From Baseline to Week 12', 'timeFrame': 'Baseline and week 12', 'description': 'N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in the blood are used for screening, diagnosis of acute congestive heart failure (CHF) and may be useful to establish prognosis in heart failure.'}, {'measure': 'World Health Organization (WHO) Functional Class - Change From Baseline to Week 12', 'timeFrame': 'Baseline and week 12', 'description': 'The WHO functional assessment of pulmonary arterial hypertension ranged from functional class I (participants with PH but without resulting limitation of physical activity) to class IV (participants with PH with inability to carry out any physical activity without symptoms. These participants manifest signs of right-heart failure.). Changes to a lower WHO functional class resemble improvement; changes to a higher functional class resemble deterioration of PAH.'}, {'measure': 'Percentage of Participants With Clinical Worsening', 'timeFrame': 'At week 12', 'description': 'The combined endpoint "time to clinical worsening", made up of the following components, defined by the first occurrence: all-cause mortality; heart/lung transplantation; atrial septostomy; first hospitalization due to pulmonary hypertension; start of a new pulmonary hypertension treatment; persistent worsening of 6MWD or WHO functional class due to deterioration of PH .'}, {'measure': 'Borg CR 10 Scale - Change From Baseline to Week 12', 'timeFrame': 'Baseline and week 12', 'description': 'The Borg CR10 Scale is a participant reported outcome measure used in clinical diagnosis of e.g. breathlessness and dyspnea. It documents the participant\'s exertion during a physical test. Low values indicate low levels of exertion; high values indicate more intense exertion reported by the participant. The score ranges from 0 ("Nothing at all") to 10 ("Extremely strong - Maximal").'}, {'measure': 'EQ-5D Utility Score - Change From Baseline to Week 12', 'timeFrame': 'Baseline and week 12', 'description': 'EQ-5D utility score is a Quality-of-Life participant reported outcome measure. The utility score is calculated based on five questions concerning problems with mobility, self-care, usual activities, pain/discomfort and anxiety/depression. An increase in the utility score represents an improvement in quality of life. The score ranges from -0.594 (worst answer in all five questions) to 1 (best answer in all five questions).'}, {'measure': 'Living With Pulmonary Hypertension (LPH) Questionnaire - Change From Baseline to Week 12', 'timeFrame': 'Baseline and week 12', 'description': "The self-reported Living with Pulmonary Hypertension (LPH) questionnaire is designed to measure the effects of PH and PH-specific treatments on an individual's quality of life. The LPH total score can range from 0 (best) to 105 (worst)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pulmonary arterial hypertension', 'PH', 'Stimulator'], 'conditions': ['Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '23883383', 'type': 'RESULT', 'citation': 'Archer SL. Riociguat for pulmonary hypertension--a glass half full. N Engl J Med. 2013 Jul 25;369(4):386-8. doi: 10.1056/NEJMe1306684. No abstract available.'}, {'pmid': '23883378', 'type': 'RESULT', 'citation': 'Ghofrani HA, Galie N, Grimminger F, Grunig E, Humbert M, Jing ZC, Keogh AM, Langleben D, Kilama MO, Fritsch A, Neuser D, Rubin LJ; PATENT-1 Study Group. Riociguat for the treatment of pulmonary arterial hypertension. N Engl J Med. 2013 Jul 25;369(4):330-40. doi: 10.1056/NEJMoa1209655.'}, {'pmid': '26135803', 'type': 'RESULT', 'citation': 'Rosenkranz S, Ghofrani HA, Beghetti M, Ivy D, Frey R, Fritsch A, Weimann G, Saleh S, Apitz C. Riociguat for pulmonary arterial hypertension associated with congenital heart disease. Heart. 2015 Nov;101(22):1792-9. doi: 10.1136/heartjnl-2015-307832. Epub 2015 Jul 1.'}, {'pmid': '27326239', 'type': 'RESULT', 'citation': 'Wang C, Jing ZC, Huang YG, Zhou DX, Liu ZH, Meier C, Nikkho S, Curram J, Zhang P, He JG. Riociguat for the treatment of pulmonary hypertension: Chinese subgroup analyses and comparison. Heart Asia. 2016 May 17;8(1):74-82. doi: 10.1136/heartasia-2015-010712. eCollection 2016.'}, {'pmid': '27263466', 'type': 'RESULT', 'citation': 'Ghofrani HA, Humbert M, Langleben D, Schermuly R, Stasch JP, Wilkins MR, Klinger JR. Riociguat: Mode of Action and Clinical Development in Pulmonary Hypertension. Chest. 2017 Feb;151(2):468-480. doi: 10.1016/j.chest.2016.05.024. Epub 2016 Jun 2.'}, {'pmid': '34848133', 'type': 'RESULT', 'citation': 'Benza RL, Boucly A, Farber HW, Frost AE, Ghofrani HA, Hoeper MM, Lambelet M, Rahner C, Bansilal S, Nikkho S, Meier C, Sitbon O. Change in REVEAL Lite 2 risk score predicts outcomes in patients with pulmonary arterial hypertension in the PATENT study. J Heart Lung Transplant. 2022 Mar;41(3):411-420. doi: 10.1016/j.healun.2021.10.013. Epub 2021 Oct 28.'}, {'pmid': '35256218', 'type': 'RESULT', 'citation': 'Benza RL, Farber HW, Frost AE, Ghofrani HA, Corris PA, Lambelet M, Nikkho S, Meier C, Hoeper MM. Application of the REVEAL risk score calculator 2.0 in the CHEST study. Respir Med. 2022 Apr-May;195:106783. doi: 10.1016/j.rmed.2022.106783. Epub 2022 Mar 1.'}, {'pmid': '34353714', 'type': 'DERIVED', 'citation': 'Benza RL, Ghofrani HA, Grunig E, Hoeper MM, Jansa P, Jing ZC, Kim NH, Langleben D, Simonneau G, Wang C, Busse D, Meier C, Ghio S. Effect of riociguat on right ventricular function in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. J Heart Lung Transplant. 2021 Oct;40(10):1172-1180. doi: 10.1016/j.healun.2021.06.020. Epub 2021 Jul 10.'}, {'pmid': '27457511', 'type': 'DERIVED', 'citation': 'Humbert M, Coghlan JG, Ghofrani HA, Grimminger F, He JG, Riemekasten G, Vizza CD, Boeckenhoff A, Meier C, de Oliveira Pena J, Denton CP. Riociguat for the treatment of pulmonary arterial hypertension associated with connective tissue disease: results from PATENT-1 and PATENT-2. Ann Rheum Dis. 2017 Feb;76(2):422-426. doi: 10.1136/annrheumdis-2015-209087. Epub 2016 Jul 25.'}, {'pmid': '27162632', 'type': 'DERIVED', 'citation': 'Saleh S, Becker C, Frey R, Muck W. Population pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of riociguat in patients with pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension. Pulm Circ. 2016 Mar;6(Suppl 1):S86-96. doi: 10.1086/685404.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.bayer.com/study/12934', 'label': "Click here to find further information and, after study completion, the study results according to Bayer's transparency standards"}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the efficacy and safety of different doses of BAY63-2521 given orally for 12 weeks, in patients with symptomatic Pulmonary Arterial Hypertension (PAH).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients with symptomatic PAH (Idiopathic, Familial, Associated PAH due to connective tissue disease, congenital heart disease, portal hypertension with liver cirrhosis, or due to anorexigen or amphetamine use)\n* Treatment naive patients and patients pre-treated with an 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